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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

StatusRecruiting
PhasePhase 4
SponsorAbbVie
Started2025-07-24
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 14 times since 2025-06-24; most recent filed 2026-08-13. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-29.

2026-08-13
Amendment Study Status, Contacts/Locations v14
2026-05-11
Amendment Study Status v13
2026-01-08
Amendment Study Status, Contacts/Locations v12
2025-12-23
Amendment Study Status, Contacts/Locations v11
2025-12-22
Amendment Study Status v10
2025-12-16
Amendment Study Status v9
2025-11-21
Amendment Study Status, Contacts/Locations v8
2025-11-21
Amendment Study Status, Contacts/Locations v7
2025-09-15
Amendment Study Status, Contacts/Locations v6
2025-09-02
Amendment Study Status, Contacts/Locations v5
2025-09-01
Amendment Study Status v4
2025-08-25
Amendment Study Status v3
2025-08-19
Amendment Study Status, Contacts/Locations v2
2025-08-01
Amendment Not Yet RecruitingRecruiting Study Status, Study Description, Contacts/Locations v1
2025-06-24
Original filing
Trial Details
NCT Number NCT07044687
Lead Sponsor AbbVie
Conditions Acute Myeloid Leukemia
Enrollment 100 participants
Start Date 2025-07-24
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-14