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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
Cancer Institute (Wia) /ID# 268695
RECRUITING
Chennai
Basavatarakam Indo American Cancer Hospital & Research Institute /ID# 268692
RECRUITING
Hyderabad
Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293
RECRUITING
New Delhi
LMMF's Deenanath Mangeshkar Hospital & Research Center /ID# 268781
RECRUITING
Pune
Sahyadri Super Speciality Hospital /ID# 272074
RECRUITING
Pune
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-07-24
Estimated Completion Date: 2027-11
Participants
Target number of participants: 100
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov