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

Last updated: May 11, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

4

Condition

Leukemia

Platelet Disorders

Acute Myeloid Leukemia

Treatment

Venetoclax

Azacitidine

Clinical Study ID

NCT07044687
M23-826
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmation of acute myeloid leukemia (AML) diagnosis by 2016 World HealthOrganization (WHO) criteria, previously untreated, and ineligible for treatment withintensive 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

Exclusion Criteria:

  • History of any malignancy within 2 years prior to study entry with exception tothose noted in the protocol.

  • Have received any investigational drug 30 days prior to the first dose of study drugand have received strong CYP3A inducers within 7 days prior to the initiation ofstudy treatment.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Venetoclax
Phase: 4
Study Start date:
July 24, 2025
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Fortis Memorial Research Institute /ID# 268697

    Gurgaon, Haryana 122002
    India

    Active - Recruiting

  • Fortis Memorial Research Institute /ID# 268697

    Gurgaon 1270642, Haryana 1270260 122002
    India

    Site Not Available

  • Mazumdar Shaw Medical Center /ID# 270677

    Bengaluru, Karnataka 560099
    India

    Active - Recruiting

  • Mazumdar Shaw Medical Center /ID# 270677

    Bengaluru 1277333, Karnataka 1267701 560099
    India

    Site Not Available

  • Regional Cancer Centre /ID# 268785

    Thiruvananthapuram, Kerala 695011
    India

    Active - Recruiting

  • Regional Cancer Centre /ID# 268785

    Thiruvananthapuram 1254163, Kerala 1267254 695011
    India

    Site Not Available

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

    Pune, Maharashtra 411004
    India

    Active - Recruiting

  • Sahyadri Super Speciality Hospital /ID# 272074

    Pune, Maharashtra 411004
    India

    Active - Recruiting

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

    Pune 1259229, Maharashtra 1264418 411004
    India

    Site Not Available

  • Sahyadri Super Speciality Hospital /ID# 272074

    Pune 1259229, Maharashtra 1264418 411004
    India

    Active - Recruiting

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

    New Delhi, National Capital Territory of Delhi 110029
    India

    Active - Recruiting

  • Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293

    New Delhi, National Capital Territory of Delhi 110085
    India

    Active - Recruiting

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

    New Delhi 1261481, National Capital Territory of Delhi 1273293 110029
    India

    Site Not Available

  • Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293

    New Delhi 1261481, National Capital Territory of Delhi 1273293 110085
    India

    Active - Recruiting

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

    Bhubaneswar, Odisha 751019
    India

    Active - Recruiting

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

    Bhubaneswar 1275817, Odisha 1261029 751019
    India

    Site Not Available

  • Apollo Cancer Centre /ID# 268780

    Chennai, Tamil Nadu 600035
    India

    Active - Recruiting

  • Cancer Institute (Wia) /ID# 268695

    Chennai, Tamil Nadu 600036
    India

    Active - Recruiting

  • Apollo Cancer Centre /ID# 268780

    Chennai 1264527, Tamil Nadu 1255053 600035
    India

    Site Not Available

  • Cancer Institute (Wia) /ID# 268695

    Chennai 1264527, Tamil Nadu 1255053 600036
    India

    Active - Recruiting

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

    Hyderabad, Telangana 500034
    India

    Active - Recruiting

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

    Hyderabad 1269843, Telangana 1254788 500034
    India

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.