8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia
Part of paid clinical trials in Duarte, California.
- Sponsor
- City of Hope Medical Center
- Study ID
- NCT05263284
- Phase
- PHASE1
- Status
- Suspended
Conditions
- Acute Myeloid Leukemia
- Recurrent Acute Myeloid Leukemia
- Refractory Acute Myeloid Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 8-Chloroadenosine — DRUGGiven IV
- Venetoclax — DRUGGiven PO
Study Details
This phase I trial tests the safety, side effects, and best dose of a new 8-chloroadenosine in combination with venetoclax in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). 8-Chloroadenosine may help block the formation of growths that may become cancer. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving 8-chloroadenosine in combination with venetoclax may help prevent the disease from coming back in patients with acute myeloid leukemia.
Key Dates
- Start date
- Dec 15, 2022
- Status verified
- Apr 2026
- Primary completion
- Jan 25, 2029
- Completion
- Jan 25, 2029
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (8-chloroadenosine, venetoclax)Patients receive 8-Cl-Ado IV over 4 hours daily on days 1-5 and venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Incidence of adverse events (AEs) [ Time Frame: Up to 1 year ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | - |
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