Venetoclax + Azacitidine
Treatment for Acute Myeloid Leukemia
Typical Dosage: Venetoclax 400 mg daily; Azacitidine 75 mg/m² daily for 7 days of a 28-day cycle
Effectiveness
80%
Safety Score
35%
Clinical Trials
253
Participants
2K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
35
DangerousModerateSafe
Treatment Details
Dosage Range
Venetoclax 400 mg daily; Azacitidine 75 mg/m² daily for 7 days of a 28-day cycle
Time to Effect
1 month
Treatment Duration
Continuous until disease progression or unacceptable toxicity
Evidence Quality
HIGHConfidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$216,000
Monitoring:$75,000
Side Effect Mgmt:$45,000
Total Annual:$336,000
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POORICER
$331,000/QALY
QALYs Gained
2
Outcome-Based Costs
Cost per Responder
$506,024
Cost per Remission
$506,024
Comparison vs Azacitidine (monotherapy)
Cost Difference
+$132,000/year
More expensive
QALY Difference
+0.30 QALYs
Better outcomes
Dominance
No dominance
Venetoclax + Azacitidine Outcomes
for Acute Myeloid Leukemia
Efficacy Outcomes
Overall Effectiveness
+80%
Response Rate
+66.4%
Remission Rate
+66.4%
Common Side Effects
Neutropenia
+65%
Thrombocytopenia
+45%
Anemia
+45%
Nausea
+45%
Diarrhea
+45%
Febrile neutropenia
+35%
Fatigue
+35%
Tumor Lysis Syndrome
+3%
Sources:
Active Clinical Trials
14 active trials recruiting for Venetoclax + Azacitidine in Acute Myeloid Leukemia
Study to Assess Adverse Events and Change in Disease Activity of Oral Venetoclax in Combination With Subcutaneous (SC) or Intravenous (IV) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Standard Induction Therapy in India
NCT07044687RECRUITINGPHASE4
100 participants
INTERVENTIONAL
Gurgaon, India +10 more
Started: Jul 24, 2025
Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia
NCT03573024ACTIVE NOT RECRUITINGPHASE2
36 participants
INTERVENTIONAL
Aurora, United States
Started: Nov 28, 2018
Uproleselan, Azacitidine, and Venetoclax for the Treatment of Treatment Naive Acute Myeloid Leukemia
NCT04964505ACTIVE NOT RECRUITINGPHASE1
16 participants
INTERVENTIONAL
Sacramento, United States
Started: Jul 2, 2021
Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia
NCT06445907RECRUITINGPHASE1
32 participants
INTERVENTIONAL
Houston, United States
Started: Feb 12, 2025
Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT
NCT06783790RECRUITINGPHASE2
20 participants
INTERVENTIONAL
Tianjin, China
Started: Jan 20, 2025
Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting
NCT04128501RECRUITINGPHASE2
125 participants
INTERVENTIONAL
Houston, United States
Started: May 5, 2020
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
NCT04905810RECRUITINGPHASE2
20 participants
INTERVENTIONAL
Clovis, United States +3 more
Started: Feb 9, 2022
Study to Assess Adverse Events and Change in Disease State of Oral Venetoclax in Combination With Subcutaneous (SC) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy in China
NCT05144243ACTIVE NOT RECRUITINGPHASE4
44 participants
INTERVENTIONAL
Beijing, China +17 more
Started: Jan 6, 2022
A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
NCT04102020ACTIVE NOT RECRUITINGPHASE3
112 participants
INTERVENTIONAL
Mobile, United States +155 more
Started: Mar 26, 2020
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
NCT06557421RECRUITINGPHASE2
50 participants
INTERVENTIONAL
Marseille, France
Started: Jun 12, 2025
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
NCT06456463RECRUITINGPHASE2
83 participants
INTERVENTIONAL
Los Angeles, United States +32 more
Started: Jan 14, 2025
A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)
NCT05834244RECRUITINGPHASE1
32 participants
INTERVENTIONAL
Cleveland, United States +1 more
Started: Oct 26, 2023
Azacitidine and Venetoclax as Induction Therapy With Venetoclax Maintenance in the Elderly With AML
NCT03466294ACTIVE NOT RECRUITINGPHASE2
42 participants
INTERVENTIONAL
Aurora, United States
Started: May 15, 2018
Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia
NCT06668558RECRUITINGPHASE2
29 participants
INTERVENTIONAL
Palma de Mallorca, Spain +13 more
Started: Dec 16, 2024
Completed Clinical Trials
1 completed trial for Venetoclax + Azacitidine in Acute Myeloid Leukemia
Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients
NCT05471700COMPLETEDNA
40 participants
INTERVENTIONAL
Guanzhou, China
Started: Sep 1, 2022
Showing 20 of 261 total trials