NCT07773909

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 15, 2026

Last Update Submit

August 20, 2026

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Composite remission rate (CR + CRi) after one cycle

    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.

    Day 28 (end of cycle 1)

Secondary Outcomes (8)

  • Change in total WBC count from baseline

    Baseline and Day 28

  • Change in absolute/differential neutrophil count from baseline

    Baseline and Day 28

  • Change in haemoglobin concentration from baseline

    Baseline and Day 28

  • Change in platelet count from baseline

    Baseline and Day 28

  • Change in peripheral blood blast percentage from baseline

    Baseline and Day 28

  • +3 more secondary outcomes

Study Arms (1)

Venetoclax + Hypomethylating Agent

EXPERIMENTAL

Single arm. All participants received one 28-day cycle of venetoclax combined with either azacitidine or decitabine at investigator discretion, with antifungal prophylaxis.

Drug: VenetoclaxDrug: AzacitidineDrug: DecitabineDrug: Voriconazole

Interventions

VenetoclaxDRUG

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.

Venetoclax + Hypomethylating Agent
AzacitidineDRUG

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

Venetoclax + Hypomethylating Agent
DecitabineDRUG

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

Venetoclax + Hypomethylating Agent
VoriconazoleDRUG

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

Venetoclax + Hypomethylating Agent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Acute promyelocytic leukemia
  • Previous treatment with a hypomethylating agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhaka Medical College Hospital

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclaxAzacitidineDecitabineVoriconazole

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTriazolesAzoles

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 15, 2026

First Posted

August 19, 2026

Study Start

June 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)