Actively Recruiting
Phase 1 Trial of Oral AOH1996 for Adults with Relapsed or Refractory Acute Myeloid Leukemia Evaluating Safety and Dose
Led by City of Hope Medical Center · Updated on 2026-07-27
12
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating AOH1996, a PCNA inhibitor medication, for its safety, side effects, and best dose in adults with acute myeloid leukemia AML that has returned after improvement or has not responded to prior treatment. This phase 1 trial aims to understand how AOH1996 works to stop cancer growth and damage cancer cell DNA in relapsed or refractory AML patients. Participants receive oral AOH1996 twice daily on days 1 through 28 of each 28-day cycle. They undergo up to 2 cycles initially without disease progression or unacceptable side effects. Those who achieve remission with transfusion independence after 2 cycles may continue treatment for up to 12 total cycles. Throughout the trial, patients have bone marrow aspirations and blood sample collections. After treatment ends, participants are followed up for 30 days and up to one year. During the study, researchers monitor safety by tracking dose-limiting toxicities and adverse events. They assess anti-leukemic activity through remission rates, overall response, minimal residual disease status, transfusion independence, and survival outcomes up to two years. Pharmacokinetics and pharmacodynamics of AOH1996 are also evaluated. Participant visits include treatment cycles, laboratory tests, and follow-up assessments to understand treatment impact and safety over time.
CONDITIONS
Brief Title
A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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