8-Chloroadenosine + Venetoclax for Acute Myeloid Leukemia
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot use certain investigational agents, chemotherapy, or specific substances like grapefruit and St. John's Wort close to starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What data supports the effectiveness of the drug combination 8-Chloroadenosine and Venetoclax for treating Acute Myeloid Leukemia?
What safety data exists for 8-Chloroadenosine and Venetoclax in humans?
8-Chloroadenosine has been tested in early clinical trials for blood cancers, and no obvious blood-related toxicity was observed in mice at certain doses. Venetoclax, also known as Venclexta, has been used in various conditions and is generally considered safe, but specific side effects can occur, so it's important to discuss with a healthcare provider.678910
How is the drug combination of 8-Chloroadenosine and Venetoclax unique for treating acute myeloid leukemia?
This treatment is unique because it combines 8-Chloroadenosine with Venetoclax, a drug known for its effectiveness in improving response rates and survival in acute myeloid leukemia (AML) when used with other agents. Venetoclax works by targeting a protein that helps cancer cells survive, and its combination with 8-Chloroadenosine may offer a novel approach to enhance treatment outcomes for AML patients.12111213
Research Team
Vinod Pullarkat
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
Adults (18+) with relapsed or refractory Acute Myeloid Leukemia who have failed at least one line of therapy, are not eligible for stem cell transplant soon, and do not have active central nervous system leukemia or other serious conditions. Participants must be able to swallow capsules, not be pregnant or breastfeeding, and agree to use effective birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 8-Cl-Ado intravenously over 4 hours daily on days 1-5 and venetoclax orally once daily on days 1-28. Treatment repeats every 28 days for up to 4 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 28 days for up to 1 year.
Treatment Details
Interventions
- 8-Chloroadenosine
- Venetoclax
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator