About 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.
Eligibility criteria
Qualifiers
Documented informed consent of the participant and/or legally authorized representative.
Age: >= 18 years.
Eastern Cooperative Oncology Group (ECOG) =< 2.
Life expectancy > 3 months.
Disqualifiers
Hydroxyurea which may be continued through cycle 1.
Expected to undergo HCT within 120 days of enrollment.
Current or planned use of agents that prolong or suspected to prolong QTc.
Received strong or moderate CYP3A inducers or St. John's Wort within 7 days prior to day 1 of protocol therapy.
Trial design
Treatments tested in this trial
- 8-Chloroadenosine
- Venetoclax
Treatment groups
Sponsors and collaborators
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator