Clinical trial · Interventional
Venetoclax With Hypomethylating Agents in Newly Diagnosed AML Unfit for Intensive Chemotherapy
Short-Term Outcome of Newly Diagnosed Acute Myeloid Leukemia Treated With Hypomethylating Agents and Venetoclax in Patients Ineligible for Intensive Chemotherapy: A Single-Centre Prospective Study
- 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 single-arm interventional study evaluated the short-term outcome of one 28-day cycle of venetoclax combined with a hypomethylating agent (azacitidine or decitabine) in adults with newly diagnosed acute myeloid leukemia who could not receive intensive induction chemotherapy. Twenty-four patients were enrolled at the Department of Haematology, Dhaka Medical College Hospital, Dhaka, Bangladesh. In addition to older and comorbid patients, the cohort included younger patients for whom intensive chemotherapy was financially inaccessible - a population under-represented in existing trial and registry data. The primary endpoint was the composite remission rate (complete remission plus complete remission with incomplete haematologic recovery) assessed by bone marrow examination on Day 28. Secondary endpoints included change in complete blood count parameters, treatment-emergent adverse events, and 28-day mortality.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
| Voriconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Venetoclax + Hypomethylating Agent
- description
- Single arm. All participants received one 28-day cycle of venetoclax combined with either azacitidine or decitabine at investigator discretion, with antifungal prophylaxis.
- interventionNames
- Drug: Venetoclax
- Drug: Azacitidine
- Drug: Decitabine
- Drug: Voriconazole
Primary outcomes (1)
- measure
- Composite remission rate (CR + CRi) after one cycle
- timeFrame
- Day 28 (end of cycle 1)
- description
- Proportion of participants achieving complete remission (bone marrow blasts \<5%, absence of circulating blasts and Auer rods, no extramedullary disease, ANC ≥1000/µL, platelets ≥100,000/µL) or CR with incomplete haematologic recovery (all CR criteria except residual neutropenia or thrombocytopenia), assessed on Day 28 bone marrow examination.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed acute myeloid leukemia * Age 18 years or older * Deemed ineligible for intensive chemotherapy by the treating physician based on age (≥60 years), performance status or comorbidity, financial constraints, or patient unwillingness to receive intensive chemotherapy * Written informed consent Exclusion Criteria: * Acute promyelocytic leukemia * Previous treatment with a hypomethylating agent
References
Publications (0)
Data not yet available