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
NCT ID: NCT07044687
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2025-07-24
2027-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Venetoclax in Combination with Azacitidine
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.
Venetoclax
Oral Tablet
Azacitidine
Subcutaneous (SC) Injection
Azacitidine
Intravenous (IV) Injection
Interventions
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Venetoclax
Oral Tablet
Azacitidine
Subcutaneous (SC) Injection
Azacitidine
Intravenous (IV) Injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
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
Countries
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Central Contacts
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Related Links
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Other Identifiers
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M23-826
Identifier Type: -
Identifier Source: org_study_id