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

NCT07044687 | Recruiting Phase 4

• 1 other identifier: M23-826
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 11

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 40 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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; AML; Venetoclax; Venclexta; Azacitidine; Treatment Naïve AML; Untreated AML

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s

  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.

  Up to Approximately 29 Months

• Percentage of Participants with Post-Baseline Laboratory Abnormalities

  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).

  Up to Approximately 29 Months

Secondary Outcomes (4)

• Composite Complete Remission (CRc)

  Up to Approximately 29 Months

• Composite Complete Remission (CRc) by initiation of Cycle 2

  Up to Approximately 1 Month

• Complete Remission

  Up to Approximately 29 Months

• Overall Survival (OS)

  Up to Approximately 29 Months

Study Arms (1)

Venetoclax in Combination with Azacitidine

EXPERIMENTAL

Participants will receive venetoclax once daily in increasing doses until the study dose is achieved. Then ventoclaxwill continue once daily thereafter. Participants will receive azacitidine on Day 1-7 of each cycle. The total study duration is approximately 29 months.

Drug: Venetoclax; Drug: Azacitidine

Interventions

Venetoclax DRUG

Oral Tablet

Venetoclax in Combination with Azacitidine

Azacitidine DRUG

Subcutaneous (SC) Injection

Venetoclax in Combination with Azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• to 2 for subject ≥ 75 years of age.
• to 3 for subject ≥ 18 to 74 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (11)

Fortis Memorial Research Institute /ID# 268697

Gurgaon, Haryana, 122002, India

RECRUITING

Mazumdar Shaw Medical Center /ID# 270677

Bengaluru, Karnataka, 560099, India

RECRUITING

Regional Cancer Centre /ID# 268785

Thiruvananthapuram, Kerala, 695011, India

RECRUITING

LMMF's Deenanath Mangeshkar Hospital & Research Center /ID# 268781

Pune, Maharashtra, 411004, India

RECRUITING

Sahyadri Super Speciality Hospital /ID# 272074

Pune, Maharashtra, 411004, India

RECRUITING

All India Institute Of Medical Sciences - New Delhi /ID# 268357

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293

New Delhi, National Capital Territory of Delhi, 110085, India

RECRUITING

All India Institute Of Medical Sciences - Bhubaneswar /ID# 274879

Bhubaneswar, Odisha, 751019, India

RECRUITING

Apollo Cancer Centre /ID# 268780

Chennai, Tamil Nadu, 600035, India

RECRUITING

Cancer Institute (Wia) /ID# 268695

Chennai, Tamil Nadu, 600036, India

RECRUITING

Basavatarakam Indo American Cancer Hospital & Research Institute /ID# 268692

Hyderabad, Telangana, 500034, India

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

IN (11)