8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

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

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator