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

Official record

Identifier

NCT07044687

Recruiting locations

country

India

Interventions studied

VenetoclaxAzacitidineAzacitidine

Lead sponsor

AbbVie

Target enrolment

100 participants

Study type

INTERVENTIONAL

Phase

Phase 4

Status

Recruiting

First posted

Jul 1, 2025

Last updated on the registry

Sep 11, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Confirmation of acute myeloid leukemia (AML) diagnosis by 2016 World Health Organization (WHO) criteria, previously untreated, and ineligible for treatment with intensive chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of:

  * 0 to 2 for subject ≥ 75 years of age.
  * 0 to 3 for subject ≥ 18 to 74 years of age.

Exclusion Criteria:

* History of any malignancy within 2 years prior to study entry with exception to those noted in the protocol.
* Have received any investigational drug 30 days prior to the first dose of study drug and have received strong CYP3A inducers within 7 days prior to the initiation of study treatment.

Indexed under

Leukemia