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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 24, 2025
Primary Completion Date
November 1, 2027
Completion Date
November 1, 2027
Last Updated
January 12, 2026
100
ESTIMATED participants
Venetoclax
DRUG
Azacitidine
DRUG
Azacitidine
DRUG
Lead Sponsor
AbbVie
NCT06285890
NCT06220162
NCT04065399
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