Oral venetoclax with injectable azacitidine for newly diagnosed AML patients who cannot have intensive chemotherapy in India
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
This trial tests whether adding oral venetoclax to azacitidine injections helps adults in India with newly diagnosed acute myeloid leukemia (AML) who are not eligible for standard intensive chemotherapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 11 sites (Gurgaon, Haryana and 10 other locations) |
| Trial ID | NCT07044687 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with newly diagnosed AML who are judged ineligible for intensive chemotherapy and meet performance status and other inclusion criteria are the ideal candidates.
Not a fit: Patients who are able to receive standard intensive induction chemotherapy, have disqualifying recent malignancies, or take strong interacting drugs may not benefit or be eligible for this regimen.
Why it matters
Potential benefit: If successful, the combination could offer a tolerable, less-intensive treatment option that reduces leukemia activity for patients who cannot undergo standard induction chemotherapy.
How similar studies have performed: Other studies of venetoclax plus azacitidine in older or unfit AML patients have shown promising efficacy and safety, so this trial builds on existing clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gurgaon, Haryana and 10 other locations
- Fortis Memorial Research Institute /ID# 268697 — Gurgaon, Haryana, India (Recruiting)
- Mazumdar Shaw Medical Center /ID# 270677 — Bengaluru, Karnataka, India (Recruiting)
- Regional Cancer Centre /ID# 268785 — Thiruvananthapuram, Kerala, 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)
- Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293 — New Delhi, National Capital Territory of Delhi, India (Recruiting)
- All India Institute Of Medical Sciences - Bhubaneswar /ID# 274879 — Bhubaneswar, Odisha, India (Recruiting)
- Apollo Cancer Centre /ID# 268780 — Chennai, Tamil Nadu, India (Recruiting)
- Cancer Institute (Wia) /ID# 268695 — Chennai, Tamil Nadu, India (Recruiting)
- Basavatarakam Indo American Cancer Hospital & Research Institute /ID# 268692 — Hyderabad, Telangana, India (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.