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
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 13 to 14v17
  2. Minor Site details revised at 2 of 13 sitesv16
  3. Minor Study sites: 11 to 13v15
  4. Re-verified, no change to tracked fieldsv14
  5. Minor Study sites: 10 to 11v13
Show 11 earlier versionsHide 11 earlier versions
  1. Minor Study sites: 9 to 10v12
  2. 2 versions Re-verified since Dec 16, 2025, no change to tracked fieldsv10-v11
  3. Minor Study sites: 8 to 9v9
  4. Minor Study sites: 5 to 8v8
  5. Minor Study sites: 4 to 5v7
  6. Minor Study sites: 3 to 4v6
  7. 2 versions Re-verified since Aug 25, 2025, no change to tracked fieldsv4-v5
  8. Minor Study sites: 2 to 3v3
  9. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 1, 2025 to Jul 24, 2025
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
350 trials monitored
See 26 trials at risk
2,976 trials monitored
See 183 trials at risk
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.
Trial Details
NCT Number NCT07044687
Lead Sponsor AbbVie
Conditions
(from sponsor)
Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov