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NCT Number: NCT07044687

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fortis Memorial Research Institute /ID# 268697, Gurgaon, Haryana, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Venetoclax

Drug

Oral Tablet

Azacitidine

Drug

Subcutaneous (SC) Injection

Primary outcomes

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

    Time frame: 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.

  2. Percentage of Participants with Post-Baseline Laboratory Abnormalities

    Time frame: 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).

Secondary outcomes

  1. Composite Complete Remission (CRc)

    Time frame: 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.

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

    Time frame: 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.

  3. Complete Remission

    Time frame: 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.

  4. Overall Survival (OS)

    Time frame: Up to Approximately 29 Months

    OS is defined as the time measured from randomization until death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 4 Study of Venetoclax in Combination With Azacitidine in Indian Subjects With Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2025
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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