Vol. 13/ Núm. 1 2026 pág. 3843
https://doi.org/10.69639/arandu.v13i1.2284
Venetoclax Combination Regimens in Relapsed or Refractory
Acute Myeloid Leukemia: A Systematic Review
Regímenes de combinación con Venetoclax en la leucemia mieloide aguda recidivante o
refractaria: una revisión sistemática
Carlos Camargo
carcamargom@gmail.com
https://orcid.org/0000-0003-4045-4050
Universidad Nacional de Colombia
Colombia – Bogotá D.C.
Sebastián Villamizar Castellanos
svillamizarc@unal.edu.co
https://orcid.org/0009-0009-2365-3729
Universidad Nacional de Colombia
Colombia – Bogotá D.C.
Jenny Andrea Santisteban
jandreasanty@gmail.com
Fundación Universitaria Ciencias de la Salud
Colombia – Bogotá D.C.
Kevin Mosquera Restrepo
kevalmore95@gmail.com
https://orcid.org/0009-0008-4722-7030
Universidad Cooperativa de Colombia
Bello, Antioquia, Colombia
Gloria Ibis Tirado Romero
gloriatirado1987@gmail.com
https://orcid.org/0009-0000-3759-5448
Fundación Universitaria Ciencias de la Salud
Colombia – Bogotá D.C.
Artículo recibido: 10 abril 2026 - Aceptado para publicación:16 mayo 2026
Conflictos de intereses: Ninguno que declarar.
ABSTRACT
Purpose: This study evaluated the efficacy and safety of venetoclax combined with
chemotherapy or hypomethylating agents in adult patients with relapsed or refractory acute
myeloid leukemia who are ineligible for intensive chemotherapy. Methods: A systematic review
of randomized and observational studies was conducted using MEDLINE, Embase, and the
Cochrane Library through October 2024. Eligible studies included adult patients with relapsed or
refractory acute myeloid leukemia treated with venetoclax-based combination regimens. Primary
outcomes were overall survival, complete remission rates, and treatment-related adverse events.
Results: Of 447 identified records, 12 studies met the inclusion criteria. Venetoclax combined
with azacitidine showed improved overall survival and higher complete remission rates compared
Vol. 13/ Núm. 1 2026 pág. 3844
with decitabine-based regimens and was associated with fewer severe hematologic and infectious
adverse events. Discussion: Venetoclax combined with azacitidine demonstrated superior
efficacy and tolerability compared with decitabine-based regimens in relapsed or refractory acute
myeloid leukemia. These findings support its use in patients ineligible for intensive
chemotherapy, although further studies are needed to define responsive subgroups and long-term
outcomes.
Keywords: Leukemia, Myeloid, Acute; Antineoplastic Agents; Survival Rate; Remission
Induction
RESUMEN
Objetivo: Este estudio evaluó la eficacia y la seguridad de venetoclax en combinación con
quimioterapia o agentes hipometilantes en pacientes adultos con leucemia mieloide aguda
recidivante o refractaria no candidatos a quimioterapia intensiva. Métodos: Se realizó una revisión
sistemática de estudios aleatorizados y observacionales utilizando MEDLINE, Embase y
Cochrane Library hasta octubre de 2024. Los estudios seleccionados incluyeron a pacientes
adultos con leucemia mieloide aguda recidivante o refractaria tratados con regímenes combinados
basados en venetoclax. Los resultados principales fueron la supervivencia global, las tasas de
remisión completa y los acontecimientos adversos relacionados con el tratamiento. Resultados:
De los 447 registros identificados, 12 estudios cumplieron los criterios de inclusión. La
combinación de venetoclax y azacitidina mostró una mejor supervivencia global y tasas de
remisión completa más elevadas en comparación con los regímenes basados en decitabina,
además de asociarse con una menor incidencia de acontecimientos adversos graves de tipo
hematológico e infeccioso. Discusión: La combinación de venetoclax y azacitidina demostró una
eficacia y tolerabilidad superiores frente a los regímenes basados en decitabina en el tratamiento
de la leucemia mieloide aguda recidivante o refractaria. Estos hallazgos respaldan su uso en
pacientes no candidatos a quimioterapia intensiva, si bien se requieren estudios adicionales para
definir los subgrupos con mejor respuesta y los resultados a largo plazo.
Palabras clave: Leucemia mieloide aguda; Agentes antineoplásicos; Tasa de
supervivencia; Inducción de remisión
Todo el contenido de la Revista Científica Internacional Arandu UTIC publicado en este sitio está disponible bajo
licencia Creative Commons Atribution 4.0 International.
with decitabine-based regimens and was associated with fewer severe hematologic and infectious
adverse events. Discussion: Venetoclax combined with azacitidine demonstrated superior
efficacy and tolerability compared with decitabine-based regimens in relapsed or refractory acute
myeloid leukemia. These findings support its use in patients ineligible for intensive
chemotherapy, although further studies are needed to define responsive subgroups and long-term
outcomes.
Keywords: Leukemia, Myeloid, Acute; Antineoplastic Agents; Survival Rate; Remission
Induction
RESUMEN
Objetivo: Este estudio evaluó la eficacia y la seguridad de venetoclax en combinación con
quimioterapia o agentes hipometilantes en pacientes adultos con leucemia mieloide aguda
recidivante o refractaria no candidatos a quimioterapia intensiva. Métodos: Se realizó una revisión
sistemática de estudios aleatorizados y observacionales utilizando MEDLINE, Embase y
Cochrane Library hasta octubre de 2024. Los estudios seleccionados incluyeron a pacientes
adultos con leucemia mieloide aguda recidivante o refractaria tratados con regímenes combinados
basados en venetoclax. Los resultados principales fueron la supervivencia global, las tasas de
remisión completa y los acontecimientos adversos relacionados con el tratamiento. Resultados:
De los 447 registros identificados, 12 estudios cumplieron los criterios de inclusión. La
combinación de venetoclax y azacitidina mostró una mejor supervivencia global y tasas de
remisión completa más elevadas en comparación con los regímenes basados en decitabina,
además de asociarse con una menor incidencia de acontecimientos adversos graves de tipo
hematológico e infeccioso. Discusión: La combinación de venetoclax y azacitidina demostró una
eficacia y tolerabilidad superiores frente a los regímenes basados en decitabina en el tratamiento
de la leucemia mieloide aguda recidivante o refractaria. Estos hallazgos respaldan su uso en
pacientes no candidatos a quimioterapia intensiva, si bien se requieren estudios adicionales para
definir los subgrupos con mejor respuesta y los resultados a largo plazo.
Palabras clave: Leucemia mieloide aguda; Agentes antineoplásicos; Tasa de
supervivencia; Inducción de remisión
Todo el contenido de la Revista Científica Internacional Arandu UTIC publicado en este sitio está disponible bajo
licencia Creative Commons Atribution 4.0 International.
Vol. 13/ Núm. 1 2026 pág. 3845
INTRODUCTION
Acute myeloid leukemia (AML) is a hematologic neoplasm characterized by the clonal
proliferation of immature myeloid precursors in the bone marrow, leading to rapid progression
and a poor prognosis without appropriate treatment. Despite advances in initial treatment, relapse
remains a significant challenge for AML patients, with limited response rates and significant
toxicities associated with conventional therapies. Traditionally, intensive chemotherapy has been
the cornerstone of treatment; however, high toxicity rates and limited response have driven the
research for new therapies that are less toxic and more effective (11).
In recent years, the selective BCL-2 inhibitor, venetoclax, has emerged as a promising
therapy in combination with hypomethylating agents (such as azacitidine and decitabine) and with
conventional chemotherapies. Recent studies have demonstrated that the combination of
venetoclax with hypomethylating agents significantly improves overall response rates in patients
with relapsed or refractory AML, especially in those who are not candidates for intensive
chemotherapy due to comorbidities or advanced age. In the combination of venetoclax with
azacitidine, overall survival has shown a notable increase compared to standard treatments in
patients unfit for intensive chemotherapy, achieving complete remission rates of 66.4% compared
to 28.3% with azacitidine alone, according to the VIALE-A trial (2023) (2).
However, unresolved questions remain regarding the long-term impact of these
combinations on overall survival, as well as the biological and clinical factors that predict
treatment response. The biological heterogeneity of AML suggests that certain subgroups of
patients may benefit more from these combinations. For example, patients with FLT3 mutations
receiving venetoclax in combination with gilteritinib have demonstrated significant molecular-
level tumor burden reduction, indicating the need for further studies to validate the benefit in
specific subgroups (11,4).
The objective of this study is to evaluate the overall survival of patients with relapsed or
refractory AML treated with venetoclax in combination with chemotherapy or hypomethylating
agents.
METHODS
A systematic review of the literature was conducted to evaluate the efficacy of Venetoclax
in combination with chemotherapy or hypomethylating agents on the overall survival of patients
with relapsed or refractory acute myeloid leukemia (AML).
Selection Criteria
Studies
Randomized clinical trials, non-randomized studies, case series, and prospective and
retrospective observational studies that assessed the use of Venetoclax in combination with
chemotherapy or hypomethylating agents in patients with relapsed or refractory AML were
INTRODUCTION
Acute myeloid leukemia (AML) is a hematologic neoplasm characterized by the clonal
proliferation of immature myeloid precursors in the bone marrow, leading to rapid progression
and a poor prognosis without appropriate treatment. Despite advances in initial treatment, relapse
remains a significant challenge for AML patients, with limited response rates and significant
toxicities associated with conventional therapies. Traditionally, intensive chemotherapy has been
the cornerstone of treatment; however, high toxicity rates and limited response have driven the
research for new therapies that are less toxic and more effective (11).
In recent years, the selective BCL-2 inhibitor, venetoclax, has emerged as a promising
therapy in combination with hypomethylating agents (such as azacitidine and decitabine) and with
conventional chemotherapies. Recent studies have demonstrated that the combination of
venetoclax with hypomethylating agents significantly improves overall response rates in patients
with relapsed or refractory AML, especially in those who are not candidates for intensive
chemotherapy due to comorbidities or advanced age. In the combination of venetoclax with
azacitidine, overall survival has shown a notable increase compared to standard treatments in
patients unfit for intensive chemotherapy, achieving complete remission rates of 66.4% compared
to 28.3% with azacitidine alone, according to the VIALE-A trial (2023) (2).
However, unresolved questions remain regarding the long-term impact of these
combinations on overall survival, as well as the biological and clinical factors that predict
treatment response. The biological heterogeneity of AML suggests that certain subgroups of
patients may benefit more from these combinations. For example, patients with FLT3 mutations
receiving venetoclax in combination with gilteritinib have demonstrated significant molecular-
level tumor burden reduction, indicating the need for further studies to validate the benefit in
specific subgroups (11,4).
The objective of this study is to evaluate the overall survival of patients with relapsed or
refractory AML treated with venetoclax in combination with chemotherapy or hypomethylating
agents.
METHODS
A systematic review of the literature was conducted to evaluate the efficacy of Venetoclax
in combination with chemotherapy or hypomethylating agents on the overall survival of patients
with relapsed or refractory acute myeloid leukemia (AML).
Selection Criteria
Studies
Randomized clinical trials, non-randomized studies, case series, and prospective and
retrospective observational studies that assessed the use of Venetoclax in combination with
chemotherapy or hypomethylating agents in patients with relapsed or refractory AML were
Vol. 13/ Núm. 1 2026 pág. 3846
included. Studies that did not report overall survival data or those in which Venetoclax was not
administered as part of a combination regimen were excluded.
Participants
Studies reporting data on adult patients (over 18 years of age) with a confirmed diagnosis
of acute myeloid leukemia, who had relapsed or refractory disease and were treated with
Venetoclax in combination with chemotherapy or hypomethylating agents, were included.
Interventions
The intervention assessed was treatment with Venetoclax administered in combination with
conventional chemotherapy regimens (e.g., cytarabine, daunorubicin) or hypomethylating agents
(e.g., azacitidine, decitabine). Studies where Venetoclax was used as monotherapy were not
included.
Outcomes
The primary outcome was overall survival (OS), defined as the time from the initiation of
Venetoclax treatment until death from any cause.
Secondary outcomes included the complete remission (CR) rate, progression-free survival
(PFS), disease-free survival (DFS), and the incidence of severe adverse events (grade ≥ 3).
Search Methods for Study Identification
Systematic searches were conducted in the MEDLINE (via PubMed), Embase, Cochrane
Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov databases from
inception through October 2024. Search terms included combinations of keywords and MeSH
terms related to "Venetoclax," "acute myeloid leukemia," "AML," "relapsed," "refractory," and
"survival." Specific terms used were "Venetoclax," "acute myeloid leukemia," "relapsed,"
"refractory," "overall survival," "chemotherapy," and "hypomethylating agents."
A manual search of the reference lists of included studies and recent relevant reviews was
conducted to identify additional studies not captured by electronic databases. Experts in the field
were also contacted to identify unpublished or ongoing literature.
Data Collection and Analysis
Two reviewers independently conducted the study selection by screening titles and
abstracts to identify studies that met the inclusion criteria. Full texts of potentially eligible studies
were reviewed in detail. Discrepancies were resolved by consensus or by consulting a third
reviewer.
Data from the included studies were independently extracted by two reviewers using a
standardized form. Extracted data included study characteristics (design, sample size, type of
intervention), participant characteristics, primary and secondary outcomes, and adverse event
data. Discrepancies in data extraction were resolved by consensus.
The methodological quality of the included studies was assessed using the Cochrane tool
for assessing the risk of bias in clinical trials (for randomized studies) and the Newcastle-Ottawa
included. Studies that did not report overall survival data or those in which Venetoclax was not
administered as part of a combination regimen were excluded.
Participants
Studies reporting data on adult patients (over 18 years of age) with a confirmed diagnosis
of acute myeloid leukemia, who had relapsed or refractory disease and were treated with
Venetoclax in combination with chemotherapy or hypomethylating agents, were included.
Interventions
The intervention assessed was treatment with Venetoclax administered in combination with
conventional chemotherapy regimens (e.g., cytarabine, daunorubicin) or hypomethylating agents
(e.g., azacitidine, decitabine). Studies where Venetoclax was used as monotherapy were not
included.
Outcomes
The primary outcome was overall survival (OS), defined as the time from the initiation of
Venetoclax treatment until death from any cause.
Secondary outcomes included the complete remission (CR) rate, progression-free survival
(PFS), disease-free survival (DFS), and the incidence of severe adverse events (grade ≥ 3).
Search Methods for Study Identification
Systematic searches were conducted in the MEDLINE (via PubMed), Embase, Cochrane
Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov databases from
inception through October 2024. Search terms included combinations of keywords and MeSH
terms related to "Venetoclax," "acute myeloid leukemia," "AML," "relapsed," "refractory," and
"survival." Specific terms used were "Venetoclax," "acute myeloid leukemia," "relapsed,"
"refractory," "overall survival," "chemotherapy," and "hypomethylating agents."
A manual search of the reference lists of included studies and recent relevant reviews was
conducted to identify additional studies not captured by electronic databases. Experts in the field
were also contacted to identify unpublished or ongoing literature.
Data Collection and Analysis
Two reviewers independently conducted the study selection by screening titles and
abstracts to identify studies that met the inclusion criteria. Full texts of potentially eligible studies
were reviewed in detail. Discrepancies were resolved by consensus or by consulting a third
reviewer.
Data from the included studies were independently extracted by two reviewers using a
standardized form. Extracted data included study characteristics (design, sample size, type of
intervention), participant characteristics, primary and secondary outcomes, and adverse event
data. Discrepancies in data extraction were resolved by consensus.
The methodological quality of the included studies was assessed using the Cochrane tool
for assessing the risk of bias in clinical trials (for randomized studies) and the Newcastle-Ottawa
Vol. 13/ Núm. 1 2026 pág. 3847
scale for observational studies. Each study was evaluated for factors such as selection bias,
confounding bias, reporting bias, and other potential biases.
A qualitative synthesis of the findings from the included studies was conducted, describing
overall survival, complete remission rates, and the incidence of adverse events.
RESULTS
Search Results
During the study selection process, 447 records were identified through database searches
and specialized registries. After removing 30 duplicate studies, 417 unique studies were
evaluated. Following the evaluation of titles and abstracts, 370 studies were excluded due to lack
of relevance. A total of 47 full-text studies were assessed. Finally, 12 studies were included in the
systematic review, providing crucial information on the effectiveness of Venetoclax in
combination with other agents in the treatment of patients with relapsed or refractory AML.
Figure 1
PRISMA Flow Diagram
Primary Studies (see Table 1)
scale for observational studies. Each study was evaluated for factors such as selection bias,
confounding bias, reporting bias, and other potential biases.
A qualitative synthesis of the findings from the included studies was conducted, describing
overall survival, complete remission rates, and the incidence of adverse events.
RESULTS
Search Results
During the study selection process, 447 records were identified through database searches
and specialized registries. After removing 30 duplicate studies, 417 unique studies were
evaluated. Following the evaluation of titles and abstracts, 370 studies were excluded due to lack
of relevance. A total of 47 full-text studies were assessed. Finally, 12 studies were included in the
systematic review, providing crucial information on the effectiveness of Venetoclax in
combination with other agents in the treatment of patients with relapsed or refractory AML.
Figure 1
PRISMA Flow Diagram
Primary Studies (see Table 1)
Vol. 13/ Núm. 1 2026 pág. 3848
Overall Survival
Overall survival (OS) was evaluated in two primary studies. Fukumoto et al. (2023) (8)
reported a median OS of 287 days in patients with relapsed/refractory acute myeloid leukemia
(AML) treated with Venetoclax in combination with azacitidine or low-dose cytarabine. In the
trial by DiNardo et al. (2020) (5), the median OS in refractory AML patients treated with
Venetoclax and decitabine was 7.8 months, suggesting a moderate improvement in survival
compared to conventional treatments.
Complete and Partial Remission Rates
Remission rates were reported in all the included studies. Fukumoto et al. (2023) (8)
indicated a complete remission or complete remission with incomplete recovery (CR/CRi) rate of
73.1%, while the study by DiNardo et al. (2020) (5) reported an overall response rate (including
complete and partial remission) of 62% in refractory AML patients. The study by Che et al. (2024)
(4) compared Venetoclax combined with azacitidine versus Venetoclax combined with
decitabine, finding a higher complete remission rate in the azacitidine group (8%) compared to
the decitabine group (4%). Similarly, the partial remission rate was higher in the azacitidine group
(18%) compared to the decitabine group (10%). Wang et al. (2022) (15) also reported high
efficacy of Venetoclax combined with azacitidine, with an overall response rate of 90% in elderly
patients with relapsed/refractory AML, compared to 40% in the control group treated with
azacitidine alone.
Hematologic Parameters and Immunologic Effects
Hematologic parameters, including platelet count (PLT), white blood cells (WBC), and
hemoglobin (Hb), were evaluated in the studies by Che et al. (2024) (4) and Wang et al. (2022)
(15). Che et al. (2024) (4) found that the group treated with Venetoclax and azacitidine showed
higher platelet levels (89.95 ± 15.34 ×10⁹/L) and hemoglobin (88.35 ± 5.96 g/L) compared to the
decitabine group (81.29 ± 12.58 ×10⁹/L and 74.84 ± 7.64 g/L, respectively). Wang et al. (2022)
(15) reported significant improvements in platelet, white blood cell, and hemoglobin levels in the
group treated with Venetoclax and azacitidine compared to the control group. Additionally, a
significant reduction in CD4+ and CD3+ levels was observed after treatment in both groups, with
no significant differences between them.
Adverse Effects
Adverse effects were reported in all included studies. Fukumoto et al. (2023) (8) reported
a grade ≥ 3 neutropenia incidence of 92.6% in patients treated with Venetoclax in combination
with azacitidine or low-dose cytarabine, indicating a high incidence of myelosuppression. In the
study by Che et al. (2024) (4), the group treated with Venetoclax and decitabine showed a higher
incidence of thrombocytopenia (16%), red blood cell depletion (11%), and pulmonary infections
(6%) compared to the azacitidine group. Wang et al. (2022) (15) found similar incidences of
Overall Survival
Overall survival (OS) was evaluated in two primary studies. Fukumoto et al. (2023) (8)
reported a median OS of 287 days in patients with relapsed/refractory acute myeloid leukemia
(AML) treated with Venetoclax in combination with azacitidine or low-dose cytarabine. In the
trial by DiNardo et al. (2020) (5), the median OS in refractory AML patients treated with
Venetoclax and decitabine was 7.8 months, suggesting a moderate improvement in survival
compared to conventional treatments.
Complete and Partial Remission Rates
Remission rates were reported in all the included studies. Fukumoto et al. (2023) (8)
indicated a complete remission or complete remission with incomplete recovery (CR/CRi) rate of
73.1%, while the study by DiNardo et al. (2020) (5) reported an overall response rate (including
complete and partial remission) of 62% in refractory AML patients. The study by Che et al. (2024)
(4) compared Venetoclax combined with azacitidine versus Venetoclax combined with
decitabine, finding a higher complete remission rate in the azacitidine group (8%) compared to
the decitabine group (4%). Similarly, the partial remission rate was higher in the azacitidine group
(18%) compared to the decitabine group (10%). Wang et al. (2022) (15) also reported high
efficacy of Venetoclax combined with azacitidine, with an overall response rate of 90% in elderly
patients with relapsed/refractory AML, compared to 40% in the control group treated with
azacitidine alone.
Hematologic Parameters and Immunologic Effects
Hematologic parameters, including platelet count (PLT), white blood cells (WBC), and
hemoglobin (Hb), were evaluated in the studies by Che et al. (2024) (4) and Wang et al. (2022)
(15). Che et al. (2024) (4) found that the group treated with Venetoclax and azacitidine showed
higher platelet levels (89.95 ± 15.34 ×10⁹/L) and hemoglobin (88.35 ± 5.96 g/L) compared to the
decitabine group (81.29 ± 12.58 ×10⁹/L and 74.84 ± 7.64 g/L, respectively). Wang et al. (2022)
(15) reported significant improvements in platelet, white blood cell, and hemoglobin levels in the
group treated with Venetoclax and azacitidine compared to the control group. Additionally, a
significant reduction in CD4+ and CD3+ levels was observed after treatment in both groups, with
no significant differences between them.
Adverse Effects
Adverse effects were reported in all included studies. Fukumoto et al. (2023) (8) reported
a grade ≥ 3 neutropenia incidence of 92.6% in patients treated with Venetoclax in combination
with azacitidine or low-dose cytarabine, indicating a high incidence of myelosuppression. In the
study by Che et al. (2024) (4), the group treated with Venetoclax and decitabine showed a higher
incidence of thrombocytopenia (16%), red blood cell depletion (11%), and pulmonary infections
(6%) compared to the azacitidine group. Wang et al. (2022) (15) found similar incidences of
Vol. 13/ Núm. 1 2026 pág. 3849
adverse effects between the groups treated with Venetoclax and azacitidine and the control group,
with no significant differences.
Table 1
Results of the Included Primary Studies
Author,
Year
Objective Count
ry
Populati
on
Design N Intervent
ion
Compara
tor
Outco
mes
Key Results
DiNard
o, 2020
(5)
Assess
safety/effic
acy of
VEN +
DEC in
ND and
R/R AML
USA ≥60 yrs,
ND or
R/R
AML
Phase II 16
8
VEN +
DEC
– ORR,
OS,
DOR,
safety
ORR 62%
(R/R AML);
median OS 7.8
mo
Che,
2024 (4)
Compare
VEN +
AZA vs
VEN +
DEC in
R/R AML
China R/R
AML
RCT 20
0
VEN +
AZA
VEN +
DEC
Respons
e, CR,
PR,
labs,
AEs
ORR: 50% vs
28%; CR 8%
vs 4%; PR
18% vs 10%.
PLT 89.9 vs
81.3×10⁹/L;
Hb 88.3 vs
74.8 g/L
(p<0.01).
Higher AEs
with DEC
(thrombocytop
enia 16%,
infection 6%)
Wang,
2022
(15)
Evaluate
AZA +
VEN in
elderly R/R
AML
China ≥60 yrs,
R/R
AML
RCT 20 AZA +
VEN
AZA ORR,
PLT,
WBC,
Hb, CD
markers
, AEs
ORR 90% vs
40% (p<0.05).
↑ PLT &
WBC both
groups. ↓
CD4+, CD3+.
Similar AEs
Fukumo
to, 2023
(8)
Real-world
VEN
combinatio
ns in AML
Japan ND &
R/R
AML
Retrospect
ive
41 VEN +
AZA or
LDAC
– OS,
CR/CRi
, safety
Median OS
287 d; CR/CRi
73.1%; grade
≥3 neutropenia
92.6%
Secondary Studies (see Table 2)
Eight secondary studies were analyzed that investigated the efficacy and safety of
Venetoclax in the treatment of relapsed or refractory acute myeloid leukemia (AML). The studies
included combinations of Venetoclax with hypomethylating agents (HMA) and low-intensity
chemotherapy, with the goal of evaluating key clinical outcomes such as complete remission (CR)
rate, overall response rate (ORR), overall survival (OS), and the incidence of adverse events.
Complete Remission (CR) Rate and Overall Response Rate (ORR)
The complete remission (CR) rate showed considerable variability across studies,
depending on the therapeutic combinations used and the characteristics of the patient population.
adverse effects between the groups treated with Venetoclax and azacitidine and the control group,
with no significant differences.
Table 1
Results of the Included Primary Studies
Author,
Year
Objective Count
ry
Populati
on
Design N Intervent
ion
Compara
tor
Outco
mes
Key Results
DiNard
o, 2020
(5)
Assess
safety/effic
acy of
VEN +
DEC in
ND and
R/R AML
USA ≥60 yrs,
ND or
R/R
AML
Phase II 16
8
VEN +
DEC
– ORR,
OS,
DOR,
safety
ORR 62%
(R/R AML);
median OS 7.8
mo
Che,
2024 (4)
Compare
VEN +
AZA vs
VEN +
DEC in
R/R AML
China R/R
AML
RCT 20
0
VEN +
AZA
VEN +
DEC
Respons
e, CR,
PR,
labs,
AEs
ORR: 50% vs
28%; CR 8%
vs 4%; PR
18% vs 10%.
PLT 89.9 vs
81.3×10⁹/L;
Hb 88.3 vs
74.8 g/L
(p<0.01).
Higher AEs
with DEC
(thrombocytop
enia 16%,
infection 6%)
Wang,
2022
(15)
Evaluate
AZA +
VEN in
elderly R/R
AML
China ≥60 yrs,
R/R
AML
RCT 20 AZA +
VEN
AZA ORR,
PLT,
WBC,
Hb, CD
markers
, AEs
ORR 90% vs
40% (p<0.05).
↑ PLT &
WBC both
groups. ↓
CD4+, CD3+.
Similar AEs
Fukumo
to, 2023
(8)
Real-world
VEN
combinatio
ns in AML
Japan ND &
R/R
AML
Retrospect
ive
41 VEN +
AZA or
LDAC
– OS,
CR/CRi
, safety
Median OS
287 d; CR/CRi
73.1%; grade
≥3 neutropenia
92.6%
Secondary Studies (see Table 2)
Eight secondary studies were analyzed that investigated the efficacy and safety of
Venetoclax in the treatment of relapsed or refractory acute myeloid leukemia (AML). The studies
included combinations of Venetoclax with hypomethylating agents (HMA) and low-intensity
chemotherapy, with the goal of evaluating key clinical outcomes such as complete remission (CR)
rate, overall response rate (ORR), overall survival (OS), and the incidence of adverse events.
Complete Remission (CR) Rate and Overall Response Rate (ORR)
The complete remission (CR) rate showed considerable variability across studies,
depending on the therapeutic combinations used and the characteristics of the patient population.
Vol. 13/ Núm. 1 2026 pág. 3850
In the VIALE-A trial, reported by Hu et al. (2023) (9), the combination of Venetoclax with
azacitidine resulted in a CR rate of 66.4%, compared to 28.3% in the placebo group. Aldoss
(2021) (3) reported a CR rate of 46% in relapsed/refractory AML patients treated with Venetoclax
and hypomethylating agents. Similarly, Bewersdorf (2020) (2) reported a CR rate of 26.7% in
patients treated with Venetoclax in combination with HMA or low-dose cytarabine (LDAC). The
overall response rate (ORR) also varied significantly, ranging from 31.1% to 56.6%, being higher
when Venetoclax was administered in combination with hypomethylating agents (Shimony,
2022; Bewersdorf, 2020) (12,15).
Overall Survival (OS)
The median overall survival (OS) also showed considerable variability across studies. In
the study by Hu et al. (2023) (9), the combination of Venetoclax with azacitidine was associated
with a median OS of 14.7 months, compared to 9.6 months in the placebo group. Aldoss (2021)
(3) reported a mean OS of 7.8 months in relapsed/refractory AML patients treated with
Venetoclax and hypomethylating agents. Bewersdorf (2020) (2) reported a median OS ranging
from 3 to 6.6 months for those treated with Venetoclax in combination with HMA or LDAC.
Overall, the data suggest improved survival for patients treated with Venetoclax combinations
compared to conventional therapies.
Adverse Events
In terms of safety, the most common adverse events reported included febrile
neutropenia, grade 3/4 hematological toxicity, and early mortality. Lasica (2021) (10) indicated
that 42% of patients experienced febrile neutropenia when treated with Venetoclax in
combination with hypomethylating agents. Shimony (2022) (12) reported a 38.6% incidence of
febrile neutropenia in relapsed/refractory AML patients. Additionally, 30-day mortality was 6.1%
in patients treated with Venetoclax combinations, highlighting the importance of close monitoring
during the early stages of treatment.
Table 2
Results of the Included Systematic Reviews
Author,
Year
Objective Country Population Intervention Comparator Outcomes Key Results
Lasica, 2021
(10)
Review VEN in
hematologic
malignancies
Australia CLL, AML,
MM
VEN ± HMA Standard
therapy
ORR, CR,
OS,
toxicity
AML: OS 14.7
vs 9.6 mo
(HMA alone);
CR 66.4%; FN
42%
Guerra,
2019 (8)
Review VEN
combos in AML
USA ND & R/R
AML
VEN +
HMA/chemo
– CR/CRi,
OS
R/R AML:
CR/CRi 48–
53%; OS 3–6
mo
Hu, 2023 (9) Review VEN-
based AML
therapy
China Adult AML VEN +
HMA/chemo
Placebo/HMA CR/CRi,
OS
CR/CRi 66.4%
vs 28.3%; OS
14.7 vs 9.6 mo
In the VIALE-A trial, reported by Hu et al. (2023) (9), the combination of Venetoclax with
azacitidine resulted in a CR rate of 66.4%, compared to 28.3% in the placebo group. Aldoss
(2021) (3) reported a CR rate of 46% in relapsed/refractory AML patients treated with Venetoclax
and hypomethylating agents. Similarly, Bewersdorf (2020) (2) reported a CR rate of 26.7% in
patients treated with Venetoclax in combination with HMA or low-dose cytarabine (LDAC). The
overall response rate (ORR) also varied significantly, ranging from 31.1% to 56.6%, being higher
when Venetoclax was administered in combination with hypomethylating agents (Shimony,
2022; Bewersdorf, 2020) (12,15).
Overall Survival (OS)
The median overall survival (OS) also showed considerable variability across studies. In
the study by Hu et al. (2023) (9), the combination of Venetoclax with azacitidine was associated
with a median OS of 14.7 months, compared to 9.6 months in the placebo group. Aldoss (2021)
(3) reported a mean OS of 7.8 months in relapsed/refractory AML patients treated with
Venetoclax and hypomethylating agents. Bewersdorf (2020) (2) reported a median OS ranging
from 3 to 6.6 months for those treated with Venetoclax in combination with HMA or LDAC.
Overall, the data suggest improved survival for patients treated with Venetoclax combinations
compared to conventional therapies.
Adverse Events
In terms of safety, the most common adverse events reported included febrile
neutropenia, grade 3/4 hematological toxicity, and early mortality. Lasica (2021) (10) indicated
that 42% of patients experienced febrile neutropenia when treated with Venetoclax in
combination with hypomethylating agents. Shimony (2022) (12) reported a 38.6% incidence of
febrile neutropenia in relapsed/refractory AML patients. Additionally, 30-day mortality was 6.1%
in patients treated with Venetoclax combinations, highlighting the importance of close monitoring
during the early stages of treatment.
Table 2
Results of the Included Systematic Reviews
Author,
Year
Objective Country Population Intervention Comparator Outcomes Key Results
Lasica, 2021
(10)
Review VEN in
hematologic
malignancies
Australia CLL, AML,
MM
VEN ± HMA Standard
therapy
ORR, CR,
OS,
toxicity
AML: OS 14.7
vs 9.6 mo
(HMA alone);
CR 66.4%; FN
42%
Guerra,
2019 (8)
Review VEN
combos in AML
USA ND & R/R
AML
VEN +
HMA/chemo
– CR/CRi,
OS
R/R AML:
CR/CRi 48–
53%; OS 3–6
mo
Hu, 2023 (9) Review VEN-
based AML
therapy
China Adult AML VEN +
HMA/chemo
Placebo/HMA CR/CRi,
OS
CR/CRi 66.4%
vs 28.3%; OS
14.7 vs 9.6 mo
Vol. 13/ Núm. 1 2026 pág. 3851
Author,
Year
Objective Country Population Intervention Comparator Outcomes Key Results
Aldoss,
2021 (1)
Review VEN in
AML
USA Unfit & R/R
AML
VEN +
HMA/LDAC
HMA/LDAC CR, OS,
MRD
CR/CRi 46%;
OS 7.8 mo
(16.6 mo if
CR); MRD–
64%
Du, 2023 (6) VEN + HMA
post-transplant
USA R/R
AML/MDS
post-allo
VEN + HMA Prior tx CR/CRi,
ORR,
survival
CR/CRi 32%;
ORR 48%; 6-
mo OS 42%;
12-mo 23%
Shimony,
2022 (12)
VEN
combinations in
AML
USA ND & R/R
AML
VEN combos Subgroups ORR, CR,
MRD, FN
R/R AML:
ORR 56.6%;
CR 24.4%;
MRD– 57.8%;
FN 38.6%; 30-
d mortality
6.1%
Wei, 2024
(16)
VEN +
demethylating
agents in elderly
AML
China >60 yrs
AML
VEN + HMA – CR, ORR,
OS
CR 70%; ORR
53%; OS 7.7–
16.9 mo
Bewersdorf,
2020 (2)
VEN in R/R
AML
USA R/R AML VEN ±
HMA/LDAC
– ORR,
CR/CRi,
OS
ORR 31.1%
(38.7%
combo);
CR/CRi 26.7%;
OS 1.8–7.8 mo
(mono), 3–6.6
mo (combo)
Risk of Bias Assessment of Included Studies
Cohort Studies: The study by Fukumoto et al. (2023) (8) on the safety and efficacy of
Venetoclax for acute myeloid leukemia (AML) in real-world clinical practice presents a "fair
quality" risk of bias rating, with a total score of 6. The representativeness of the exposed cohort
is considered adequate, but the lack of an unexposed cohort and the absence of comparability
between cohorts limit the comparative analysis. The verification of drug use and outcome
assessment were well-documented, with secure records and independent blind evaluation,
respectively. Additionally, the study is notable for complete follow-up and sufficient duration for
observing outcomes. However, the absence of a comparison group reduces the ability to assess
the differential impact of the treatment.
Clinical Trials: The studies by Che et al. (2024) (4) and Wang et al. (2022) (15) evaluated
the use of Venetoclax in combination with azacitidine or decitabine in relapsed/refractory acute
myeloid leukemia. Both studies show a low risk of bias in the domains related to the
randomization process, missing outcome data, and outcome measurement, indicating good
methodological quality in these areas. However, "some concerns" were identified in the domains
related to deviations from the intended interventions and selection of the reported outcome, which
Author,
Year
Objective Country Population Intervention Comparator Outcomes Key Results
Aldoss,
2021 (1)
Review VEN in
AML
USA Unfit & R/R
AML
VEN +
HMA/LDAC
HMA/LDAC CR, OS,
MRD
CR/CRi 46%;
OS 7.8 mo
(16.6 mo if
CR); MRD–
64%
Du, 2023 (6) VEN + HMA
post-transplant
USA R/R
AML/MDS
post-allo
VEN + HMA Prior tx CR/CRi,
ORR,
survival
CR/CRi 32%;
ORR 48%; 6-
mo OS 42%;
12-mo 23%
Shimony,
2022 (12)
VEN
combinations in
AML
USA ND & R/R
AML
VEN combos Subgroups ORR, CR,
MRD, FN
R/R AML:
ORR 56.6%;
CR 24.4%;
MRD– 57.8%;
FN 38.6%; 30-
d mortality
6.1%
Wei, 2024
(16)
VEN +
demethylating
agents in elderly
AML
China >60 yrs
AML
VEN + HMA – CR, ORR,
OS
CR 70%; ORR
53%; OS 7.7–
16.9 mo
Bewersdorf,
2020 (2)
VEN in R/R
AML
USA R/R AML VEN ±
HMA/LDAC
– ORR,
CR/CRi,
OS
ORR 31.1%
(38.7%
combo);
CR/CRi 26.7%;
OS 1.8–7.8 mo
(mono), 3–6.6
mo (combo)
Risk of Bias Assessment of Included Studies
Cohort Studies: The study by Fukumoto et al. (2023) (8) on the safety and efficacy of
Venetoclax for acute myeloid leukemia (AML) in real-world clinical practice presents a "fair
quality" risk of bias rating, with a total score of 6. The representativeness of the exposed cohort
is considered adequate, but the lack of an unexposed cohort and the absence of comparability
between cohorts limit the comparative analysis. The verification of drug use and outcome
assessment were well-documented, with secure records and independent blind evaluation,
respectively. Additionally, the study is notable for complete follow-up and sufficient duration for
observing outcomes. However, the absence of a comparison group reduces the ability to assess
the differential impact of the treatment.
Clinical Trials: The studies by Che et al. (2024) (4) and Wang et al. (2022) (15) evaluated
the use of Venetoclax in combination with azacitidine or decitabine in relapsed/refractory acute
myeloid leukemia. Both studies show a low risk of bias in the domains related to the
randomization process, missing outcome data, and outcome measurement, indicating good
methodological quality in these areas. However, "some concerns" were identified in the domains
related to deviations from the intended interventions and selection of the reported outcome, which
Vol. 13/ Núm. 1 2026 pág. 3852
could limit the interpretation of the treatment effects. The presence of these concerns highlights
the importance of transparency in outcome reporting and the need to minimize potential biases in
outcome selection.
Table 3
Risk of Bias Assessment of Clinical Trials
Domain Che, 2024
(4)
Wang, 2022
(15)
Domain 1: Risk of bias arising from the randomization
process
Low Low
Domain 2: Risk of bias due to deviations from intended
interventions (effect of assignment to intervention)
Some
concerns
Some
concerns
Domain 3: Risk of bias due to missing outcome data Low Low
Domain 4: Risk of bias in measurement of the outcome Low Low
Domain 5: Risk of bias in selection of the reported result Some
concerns
Some
concerns
Systematic Reviews
Table 4 shows the risk of bias in the systematic reviews conducted by different authors.
The studies by Lasica (2021) (10), Guerra (2019) (8), Hu (2023) (9), and Aldoss (2021) (1)
presented a high risk of bias across all evaluated domains, including study eligibility criteria,
study identification and selection, data collection and evaluation, and synthesis and findings. This
suggests significant methodological issues that could affect the validity of their conclusions. In
contrast, the studies by Du (2023) (6), Shimony (2022) (12), Wei (2024) (16), and Bewersdorf
(2020) (2) presented a low risk of bias across all evaluated domains, indicating better
methodological quality and greater confidence in their results.
Table 4
Risk of Bias Assessment of Included Systematic Reviews
Domain Lasica,
2021
(10)
Guerra,
2019 (8)
Hu,
2023 (9)
Aldoss,
2021
[12]
Du,
2023
[4]
Shimony,
2022 [13]
Wei,
2024
[14]
Bewers
dorf,
2020
[15]
Domain 1: Study eligibility criteria High Low High Low Low Low Low Low
Domain 2: Identification and selection of
studies
High High High High Low Low Low Low
Domain 3: Data collection and study appraisal High High High High Low Low Low Low
Domain 4: Synthesis and findings High High High High Low Low Low Low
Overall Risk of Bias High High High High Low Low Low Low
Table 5
Abbreviations
Abbreviation Definition
AML Acute Myeloid Leukemia
BCL-2 B-cell Lymphoma 2
CR Complete Remission
could limit the interpretation of the treatment effects. The presence of these concerns highlights
the importance of transparency in outcome reporting and the need to minimize potential biases in
outcome selection.
Table 3
Risk of Bias Assessment of Clinical Trials
Domain Che, 2024
(4)
Wang, 2022
(15)
Domain 1: Risk of bias arising from the randomization
process
Low Low
Domain 2: Risk of bias due to deviations from intended
interventions (effect of assignment to intervention)
Some
concerns
Some
concerns
Domain 3: Risk of bias due to missing outcome data Low Low
Domain 4: Risk of bias in measurement of the outcome Low Low
Domain 5: Risk of bias in selection of the reported result Some
concerns
Some
concerns
Systematic Reviews
Table 4 shows the risk of bias in the systematic reviews conducted by different authors.
The studies by Lasica (2021) (10), Guerra (2019) (8), Hu (2023) (9), and Aldoss (2021) (1)
presented a high risk of bias across all evaluated domains, including study eligibility criteria,
study identification and selection, data collection and evaluation, and synthesis and findings. This
suggests significant methodological issues that could affect the validity of their conclusions. In
contrast, the studies by Du (2023) (6), Shimony (2022) (12), Wei (2024) (16), and Bewersdorf
(2020) (2) presented a low risk of bias across all evaluated domains, indicating better
methodological quality and greater confidence in their results.
Table 4
Risk of Bias Assessment of Included Systematic Reviews
Domain Lasica,
2021
(10)
Guerra,
2019 (8)
Hu,
2023 (9)
Aldoss,
2021
[12]
Du,
2023
[4]
Shimony,
2022 [13]
Wei,
2024
[14]
Bewers
dorf,
2020
[15]
Domain 1: Study eligibility criteria High Low High Low Low Low Low Low
Domain 2: Identification and selection of
studies
High High High High Low Low Low Low
Domain 3: Data collection and study appraisal High High High High Low Low Low Low
Domain 4: Synthesis and findings High High High High Low Low Low Low
Overall Risk of Bias High High High High Low Low Low Low
Table 5
Abbreviations
Abbreviation Definition
AML Acute Myeloid Leukemia
BCL-2 B-cell Lymphoma 2
CR Complete Remission
Vol. 13/ Núm. 1 2026 pág. 3853
Abbreviation Definition
CRi Complete Remission with Incomplete Recovery
DFS Disease-Free Survival
FN Febrile Neutropenia
Hb Hemoglobin
HMA Hypomethylating Agent
IRB Institutional Review Board
LDAC Low-Dose Cytarabine
MDS Myelodysplastic Syndrome
MRD Minimal Residual Disease
ORR Overall Response Rate
OS Overall Survival
PFS Progression-Free Survival
PLT Platelet Count
PR Partial Remission
R/R Relapsed or Refractory
WBC White Blood Cell Count
The following abbreviations are used in this manuscript:
DISCUSSION
This study evaluated the efficacy of Venetoclax combined with hypomethylating agents
and chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML). The
findings showed improved overall survival (OS) and high complete remission (CR) rates,
particularly with Venetoclax plus azacitidine, especially in elderly patients and those with
comorbidities who are not candidates for intensive chemotherapy. A recent meta-analysis
reported a CR/CRi rate of 32%, an overall response rate (ORR) of 48%, and a 6-month survival
of 42%, supporting the benefit of Venetoclax-based combinations in high-risk patients.
A lower incidence of severe adverse events was observed with Venetoclax plus azacitidine
compared with Venetoclax plus decitabine. Although both regimens are viable, azacitidine-based
combinations demonstrated superior safety and tolerability, supporting their use in patients unfit
for intensive chemotherapy (6).
These results are consistent with previous studies, including the VIALE-A trial, which
reported higher CR rates (66.4% vs 28.3%) and longer median OS (14.7 months) with Venetoclax
plus azacitidine compared with azacitidine alone, findings comparable to those reported by
Abbreviation Definition
CRi Complete Remission with Incomplete Recovery
DFS Disease-Free Survival
FN Febrile Neutropenia
Hb Hemoglobin
HMA Hypomethylating Agent
IRB Institutional Review Board
LDAC Low-Dose Cytarabine
MDS Myelodysplastic Syndrome
MRD Minimal Residual Disease
ORR Overall Response Rate
OS Overall Survival
PFS Progression-Free Survival
PLT Platelet Count
PR Partial Remission
R/R Relapsed or Refractory
WBC White Blood Cell Count
The following abbreviations are used in this manuscript:
DISCUSSION
This study evaluated the efficacy of Venetoclax combined with hypomethylating agents
and chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML). The
findings showed improved overall survival (OS) and high complete remission (CR) rates,
particularly with Venetoclax plus azacitidine, especially in elderly patients and those with
comorbidities who are not candidates for intensive chemotherapy. A recent meta-analysis
reported a CR/CRi rate of 32%, an overall response rate (ORR) of 48%, and a 6-month survival
of 42%, supporting the benefit of Venetoclax-based combinations in high-risk patients.
A lower incidence of severe adverse events was observed with Venetoclax plus azacitidine
compared with Venetoclax plus decitabine. Although both regimens are viable, azacitidine-based
combinations demonstrated superior safety and tolerability, supporting their use in patients unfit
for intensive chemotherapy (6).
These results are consistent with previous studies, including the VIALE-A trial, which
reported higher CR rates (66.4% vs 28.3%) and longer median OS (14.7 months) with Venetoclax
plus azacitidine compared with azacitidine alone, findings comparable to those reported by
Vol. 13/ Núm. 1 2026 pág. 3854
Fukumoto et al. (2023) (8). High response rates have also been observed in elderly populations
treated with this combination (14).
In contrast, Venetoclax combined with decitabine showed lower remission rates and a
higher frequency of adverse events, including thrombocytopenia and pulmonary infections,
limiting its applicability in certain subgroups (6,7,13). These differences highlight the importance
of selecting the appropriate hypomethylating agent based on patient characteristics and treatment
tolerability.
This study has limitations related to the heterogeneity of included study designs,
populations, and inclusion criteria, which may affect comparability and limit definitive
conclusions. However, this heterogeneity reflects real-world clinical practice and enhances the
external applicability of the findings.
Strengths of this review include the inclusion of diverse patient populations and real-world
data, as well as the integration of randomized and observational studies, providing a
comprehensive assessment of Venetoclax-based combinations in relapsed or refractory AML.
Clinically, Venetoclax combined with hypomethylating agents, particularly azacitidine,
represents a valuable therapeutic option for patients unfit for intensive therapy. Further research
should focus on identifying predictive biomarkers, including genetic subgroups such as FLT3-
ITD, and on evaluating long-term survival and quality-of-life outcomes (4).
CONCLUSION
This study provides robust evidence on the efficacy and safety of Venetoclax in
combination with hypomethylating agents in the treatment of relapsed or refractory AML.
Combinations with azacitidine proved to be superior in terms of remission rates and adverse
effects compared to decitabine, suggesting that this combination should be considered as a first-
line option in these patients. Future research should focus on optimizing patient selection and
addressing remaining questions about the long-term impact of these therapies, as well as exploring
new combinations that could improve outcomes in AML patients and other hematologic
malignancies.
Fukumoto et al. (2023) (8). High response rates have also been observed in elderly populations
treated with this combination (14).
In contrast, Venetoclax combined with decitabine showed lower remission rates and a
higher frequency of adverse events, including thrombocytopenia and pulmonary infections,
limiting its applicability in certain subgroups (6,7,13). These differences highlight the importance
of selecting the appropriate hypomethylating agent based on patient characteristics and treatment
tolerability.
This study has limitations related to the heterogeneity of included study designs,
populations, and inclusion criteria, which may affect comparability and limit definitive
conclusions. However, this heterogeneity reflects real-world clinical practice and enhances the
external applicability of the findings.
Strengths of this review include the inclusion of diverse patient populations and real-world
data, as well as the integration of randomized and observational studies, providing a
comprehensive assessment of Venetoclax-based combinations in relapsed or refractory AML.
Clinically, Venetoclax combined with hypomethylating agents, particularly azacitidine,
represents a valuable therapeutic option for patients unfit for intensive therapy. Further research
should focus on identifying predictive biomarkers, including genetic subgroups such as FLT3-
ITD, and on evaluating long-term survival and quality-of-life outcomes (4).
CONCLUSION
This study provides robust evidence on the efficacy and safety of Venetoclax in
combination with hypomethylating agents in the treatment of relapsed or refractory AML.
Combinations with azacitidine proved to be superior in terms of remission rates and adverse
effects compared to decitabine, suggesting that this combination should be considered as a first-
line option in these patients. Future research should focus on optimizing patient selection and
addressing remaining questions about the long-term impact of these therapies, as well as exploring
new combinations that could improve outcomes in AML patients and other hematologic
malignancies.
Vol. 13/ Núm. 1 2026 pág. 3855
REFERENCES
1. Aldoss, I., Pullarkat, V., & Stein, A. S. (2021). Venetoclax-containing regimens in acute
myeloid leukemia. Therapeutic Advances in Hematology, 12, 2040620720986646.
https://doi.org/10.1177/2040620720986646
2. Bewersdorf, J. P., Giri, S., Wang, R., Williams, R. T., Tallman, M. S., Zeidan, A. M., et al.
(2020). Venetoclax as monotherapy and in combination with hypomethylating agents or
low-dose cytarabine in relapsed and treatment-refractory acute myeloid leukemia: A
systematic review and meta-analysis. Haematologica, 105, 2659–2663.
https://doi.org/10.3324/haematol.2020.256248
3. Burnett, A., & Stone, R. (2020). AML: New drugs but new challenges. Clinical
Lymphoma, Myeloma & Leukemia, 20(6), 341–350.
https://doi.org/10.1016/j.clml.2020.02.018
4. Che, Y., Tan, W., Liu, Y., Liu, H., Li, L., & Qin, F. (2024). Venetoclax in combination
with azacitidine or decitabine in relapsed/refractory acute myeloid leukemia. Tropical
Journal of Pharmaceutical Research, 23, 209–214.
5. DiNardo, C. D., Maiti, A., Rausch, C. R., Pemmaraju, N., Naqvi, K., Daver, N. G., et al.
(2020). 10-day decitabine with venetoclax for newly diagnosed intensive chemotherapy-
ineligible and relapsed or refractory acute myeloid leukemia: A single-centre, phase 2 trial.
The Lancet Haematology, 7, e724–e736. https://doi.org/10.1016/S2352-3026(20)30204-5
6. Du, Y., Li, C., Zhao, Z., Liu, Y., Zhang, C., & Yan, J. (2023). Efficacy and safety of
venetoclax combined with hypomethylating agents for relapse of acute myeloid leukemia
and myelodysplastic syndrome post-allogeneic hematopoietic stem cell transplantation: A
systematic review and meta-analysis. BMC Cancer, 23, 764.
https://doi.org/10.1186/s12885-023-11130-5
7. Gong, X., He, X., Wang, L., Yu, T., Liu, W., Xu, H., et al. (2024). Venetoclax-based
therapy for relapsed or refractory acute myeloid leukemia: Latest updates from the 2023
ASH annual meeting. Experimental Hematology & Oncology, 13, 17.
8. Guerra, V. A., DiNardo, C., & Konopleva, M. (2019). Venetoclax-based therapies for acute
myeloid leukemia. Best Practice & Research Clinical Haematology, 32, 145–153.
9. Hu, M., Li, W., Zhang, Y., Liang, C., Tan, J., & Wang, Y. (2023). Venetoclax in adult
acute myeloid leukemia. Biomedicine & Pharmacotherapy, 168, 115820.
10. Lasica, M., & Anderson, M. A. (2021). Review of venetoclax in CLL, AML and multiple
myeloma. Journal of Personalized Medicine, 11, 457.
https://doi.org/10.3390/jpm11060457
11. MD Anderson Cancer Center. (n.d.). Venetoclax combination therapies found effective
against challenging subtypes of acute myeloid leukemia.
REFERENCES
1. Aldoss, I., Pullarkat, V., & Stein, A. S. (2021). Venetoclax-containing regimens in acute
myeloid leukemia. Therapeutic Advances in Hematology, 12, 2040620720986646.
https://doi.org/10.1177/2040620720986646
2. Bewersdorf, J. P., Giri, S., Wang, R., Williams, R. T., Tallman, M. S., Zeidan, A. M., et al.
(2020). Venetoclax as monotherapy and in combination with hypomethylating agents or
low-dose cytarabine in relapsed and treatment-refractory acute myeloid leukemia: A
systematic review and meta-analysis. Haematologica, 105, 2659–2663.
https://doi.org/10.3324/haematol.2020.256248
3. Burnett, A., & Stone, R. (2020). AML: New drugs but new challenges. Clinical
Lymphoma, Myeloma & Leukemia, 20(6), 341–350.
https://doi.org/10.1016/j.clml.2020.02.018
4. Che, Y., Tan, W., Liu, Y., Liu, H., Li, L., & Qin, F. (2024). Venetoclax in combination
with azacitidine or decitabine in relapsed/refractory acute myeloid leukemia. Tropical
Journal of Pharmaceutical Research, 23, 209–214.
5. DiNardo, C. D., Maiti, A., Rausch, C. R., Pemmaraju, N., Naqvi, K., Daver, N. G., et al.
(2020). 10-day decitabine with venetoclax for newly diagnosed intensive chemotherapy-
ineligible and relapsed or refractory acute myeloid leukemia: A single-centre, phase 2 trial.
The Lancet Haematology, 7, e724–e736. https://doi.org/10.1016/S2352-3026(20)30204-5
6. Du, Y., Li, C., Zhao, Z., Liu, Y., Zhang, C., & Yan, J. (2023). Efficacy and safety of
venetoclax combined with hypomethylating agents for relapse of acute myeloid leukemia
and myelodysplastic syndrome post-allogeneic hematopoietic stem cell transplantation: A
systematic review and meta-analysis. BMC Cancer, 23, 764.
https://doi.org/10.1186/s12885-023-11130-5
7. Gong, X., He, X., Wang, L., Yu, T., Liu, W., Xu, H., et al. (2024). Venetoclax-based
therapy for relapsed or refractory acute myeloid leukemia: Latest updates from the 2023
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leukemia: A systematic review and meta-analysis. Haematologica, 107, 2955–2960.
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with venetoclax plus hypomethylating agents at a comprehensive cancer center. Frontiers
in Oncology, 11, 649209. https://doi.org/10.3389/fonc.2021.649209
14. Wang, H., Mao, L., Yang, M., Qian, P., Lu, H., Tong, H., et al. (2022). Venetoclax plus 3
+ 7 daunorubicin and cytarabine chemotherapy as first-line treatment for adults with acute
myeloid leukemia: A multicenter, single-arm, phase 2 trial. The Lancet Haematology, 9,
e415–e423.
15. Wang, W., Luo, Q., Chen, Q., Pang, A., & Fang, K. (2022). Analysis of the clinical efficacy
of azacitidine plus venetoclax in the treatment of elderly patients with relapsed refractory
acute myeloid leukemia. Evidence-Based Complementary and Alternative Medicine, 2022,
1–8.
16. Wei, M. Y., Yin, J., Liao, Y., Liu, J. Y., Zhao, Y., Chen, X. M., et al. (2024). The efficacy
and safety of venetoclax combined with demethylating agents in elderly patients with acute
myeloid leukemia: A systematic review and meta-analysis. European Review for Medical
and Pharmacological Sciences, 28, 1837–1846.