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
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 14
- Primary Endpoint
- Percentage of Participants with Post-Baseline Laboratory Abnormalities
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Venetoclax in Combination with Azacitidine
Participants will receive venetoclax once daily in increasing doses until the study dose is achieved. Then ventoclaxwill continue once daily thereafter. Participants will receive azacitidine on Day 1-7 of each cycle. The total study duration is approximately 29 months.
Intervention: Azacitidine (Drug)
Venetoclax in Combination with Azacitidine
Participants will receive venetoclax once daily in increasing doses until the study dose is achieved. Then ventoclaxwill continue once daily thereafter. Participants will receive azacitidine on Day 1-7 of each cycle. The total study duration is approximately 29 months.
Intervention: Venetoclax (Drug)
Outcomes
Primary Outcomes
Percentage of Participants with Post-Baseline Laboratory Abnormalities
Time Frame: Up to Approximately 29 Months
Laboratory abnormalities are defined based on the shifts from baseline to postbaseline laboratory values will be summarized using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Percentage of Participants with Post-Baseline Laboratory Abnormalities
Time Frame: Up to Approximately 29 Months
Laboratory abnormalities are defined based on the shifts from baseline to postbaseline laboratory values will be summarized using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s
Time Frame: Up to Approximately 29 Months
TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
Secondary Outcomes
- Composite Complete Remission (CRc)(Up to Approximately 29 Months)
- Composite Complete Remission (CRc) by initiation of Cycle 2(Up to Approximately 1 Month)
- Composite Complete Remission (CRc)(Up to Approximately 29 Months)
- Overall Survival (OS)(Up to Approximately 29 Months)
- Composite Complete Remission (CRc) by initiation of Cycle 2(Up to Approximately 1 Month)
- Complete Remission(Up to Approximately 29 Months)