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

Not Applicable

Not yet recruiting

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT07044687
• Lead Sponsor: AbbVie

Brief Summary

Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo standard induction therapy, the current standard of care. This study will assess the change in disease activity and adverse events in adult participants with acute myeloid leukemia (AML) being treated with of the combination of azacitidine and venetoclax, in India.

The combination of azacitidine and venetoclax is being evaluated in the treatment of acute myeloid leukemia (AML). Participants will receive azacitidine with increasing doses of venetoclax. Around 100 adult participants with a diagnosis of AML will be enrolled in the study at approximately 15 sites in India.

Participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous (SC) or intravenous (IV) injection on Days 1-7 of each cycle. The total study duration is approximately 29 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study Start: 2025-07-01
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2027-11
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Post-Baseline Laboratory Abnormalities	Up to Approximately 29 Months	Laboratory abnormalities are defined based on the shifts from baseline to postbaseline laboratory values will be summarized using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s	Up to Approximately 29 Months	TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.

Secondary Outcome Measures

Name	Time	Method
Composite Complete Remission (CRc)	Up to Approximately 29 Months	(CRc) is defined as Complete remission (CR) or complete remission with incomplete marrow recovery (CRi) per the modified International Working Group (IWG) response criteria for AML in participants who received venetoclax and azacitidine combination study treatment.
Overall Survival (OS)	Up to Approximately 29 Months	OS is defined as the time measured from randomization until death from any cause.
Composite Complete Remission (CRc) by initiation of Cycle 2	Up to Approximately 1 Month	(CRc) is defined as Complete remission (CR) or complete remission with incomplete marrow recovery (CRi) per the modified International Working Group (IWG) response criteria for AML in participants who received venetoclax and azacitidine combination study treatment.
Complete Remission	Up to Approximately 29 Months	CR is defined as the modified IWG response criteria for AML in participants who received venetoclax and azacitidine combination study treatment.