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

Recruiting now · Phase 4

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT07044687

Run by

AbbVie

People needed

100

Starts

2025-07-24

Expected to finish

2027-11-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Fortis Memorial Research Institute /ID# 268697 — Gurgaon, Haryana, India (enrolling)
• Mazumdar Shaw Medical Center /ID# 270677 — Bengaluru, Karnataka, India (enrolling)
• Regional Cancer Centre /ID# 268785 — Thiruvananthapuram, Kerala, India (enrolling)
• LMMF's Deenanath Mangeshkar Hospital & Research Center /ID# 268781 — Pune, Maharashtra, India (enrolling)
• Sahyadri Super Speciality Hospital /ID# 272074 — Pune, Maharashtra, India (enrolling)
• All India Institute Of Medical Sciences - New Delhi /ID# 268357 — New Delhi, National Capital Territory of Delhi, India (enrolling)
• Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293 — New Delhi, National Capital Territory of Delhi, India (enrolling)
• All India Institute Of Medical Sciences - Bhubaneswar /ID# 274879 — Bhubaneswar, Odisha, India (enrolling)
• Apollo Cancer Centre /ID# 268780 — Chennai, Tamil Nadu, India (enrolling)
• Cancer Institute (Wia) /ID# 268695 — Chennai, Tamil Nadu, India (enrolling)
• Basavatarakam Indo American Cancer Hospital & Research Institute /ID# 268692 — Hyderabad, Telangana, India (enrolling)

Full record on ClinicalTrials.gov

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