Oral venetoclax with injectable azacitidine for newly diagnosed AML patients who cannot have intensive chemotherapy in India

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label interventional study enrolls adults with newly diagnosed AML in India who are ineligible for intensive induction chemotherapy. Participants will receive oral venetoclax with a dose ramp-up to a target dose, continued once daily, together with azacitidine given by subcutaneous or intravenous injection. About 40 participants will be treated across roughly 15 sites in India. The study will track changes in disease activity and adverse events to characterize safety and treatment response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* History of any malignancy within 2 years prior to study entry with exception to those noted in the protocol.
* 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.

Where it's running

• Mazumdar Shaw Medical Center /ID# 270677
  Bengaluru, Karnataka, India Recruiting
• Regional Cancer Centre /ID# 268785
  Thiruvananthapuram, Kerala, India Recruiting
• Tata Memorial Hospital - Mumbai /ID# 269177
  Mumbai, Maharashtra, India Recruiting
• LMMF's Deenanath Mangeshkar Hospital & Research Center /ID# 268781
  Pune, Maharashtra, India Recruiting
• Sahyadri Super Speciality Hospital /ID# 272074
  Pune, Maharashtra, India Recruiting
• All India Institute Of Medical Sciences - New Delhi /ID# 268357
  New Delhi, National Capital Territory of Delhi, India Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.