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Venetoclax With Hypomethylating Agents in Newly Diagnosed AML Unfit for Intensive Chemotherapy

NCT07773909 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-21

No results posted yet for this study

Summary

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

Interventions

DRUG

Venetoclax

Oral venetoclax 100 mg on Day 1, 200 mg on Day 2, then 100 mg daily Days 3-28. Dose maintained at 100 mg from Day 3 because of concomitant strong CYP3A4 inhibition by voriconazole.

DRUG

Azacitidine

75 mg/m² intravenously, Days 1-7 of the 28-day cycle.

DRUG

Decitabine

20 mg/m² intravenously, Days 1-5 of the 28-day cycle.

DRUG

Voriconazole

200 mg orally twice daily, Days 3-28, as antifungal prophylaxis.

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-03-01
Completion
2023-03-01

Countries

  • Bangladesh

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07773909 on ClinicalTrials.gov