RecruitingPhase 4NCT07044687

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

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


Sponsor

AbbVie

Enrollment

100 participants

Start Date

Jul 24, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria2

  • 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.

Interventions

DRUGVenetoclax

Oral Tablet

DRUGAzacitidine

Subcutaneous (SC) Injection

DRUGAzacitidine

Intravenous (IV) Injection


Locations(11)

Fortis Memorial Research Institute /ID# 268697

Gurgaon, Haryana, India

Mazumdar Shaw Medical Center /ID# 270677

Bengaluru, Karnataka, India

Regional Cancer Centre /ID# 268785

Thiruvananthapuram, Kerala, India

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

Pune, Maharashtra, India

Sahyadri Super Speciality Hospital /ID# 272074

Pune, Maharashtra, India

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

New Delhi, National Capital Territory of Delhi, India

Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293

New Delhi, National Capital Territory of Delhi, India

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

Bhubaneswar, Odisha, India

Apollo Cancer Centre /ID# 268780

Chennai, Tamil Nadu, India

Cancer Institute (Wia) /ID# 268695

Chennai, Tamil Nadu, India

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

Hyderabad, Telangana, India

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NCT07044687


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