Clinical trial · Observational
A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study)
Prospective Non-interventional Study to Describe the Effectiveness and Safety of Venetoclax in Acute Myeloid Leukemia (AML) Patients in Routine Clinical Practice (REVIVE Study)
NCT03987958CI-TRIAL-00101041REVIVEactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will describe the safety and effectiveness of venetoclax in AML patients in routine clinical practice in Israel. The decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Venetoclax
- description
- Participants in this observational study will receive treatment with venetoclax for AML. The decision to treat with venetoclax has been made independently from this observational study before participants are offered the opportunity to participate in this study.
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Time from treatment to death from any cause, up to approximately 30 months
- description
- Overall survival is defined as the time from the date of first treatment to the date of death from any cause.
Secondary outcomes (6)
- measure
- Percentage of participants achieving composite complete remission (CR or CRi)
- timeFrame
- Approximately 30 months
- description
- The percentage of participants achieving CR or CRi will be calculated based on the modified International Working Group (IWG) criteria for AML.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant diagnosed with Acute Myeloid Leukemia (AML) and is eligible to receive venetoclax per Israel Ministry of Health. * Participant who will be treated with venetoclax and the decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study. Exclusion Criteria: \- Participant participating in an interventional trial within 30 days prior to starting venetoclax treatment.
References
Publications (1)
- DERIVEDWolach O, Levi I, Nachmias B, Tavor S, Amitai I, Ofran Y, Ganzel C, Zuckerman T, Okasha D, Hellmann I, Tadmor T, Dally N, Canaani J, Stemer G, Grunspan M, Berger AJ, Frankel N, Berelovich J, Bleterman A, Barak M, Cohen R, Moshe Y. Trial eligibility, treatment patterns, and outcome for venetoclax-based therapy in AML: a prospective cohort study. Blood Adv. 2025 Apr 8;9(7):1544-1554. doi: 10.1182/bloodadvances.2024014014. PMID 39637307