Actively Recruiting
A Phase 1 Study of AOH1996 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Led by City of Hope Medical Center · Updated on 2026-05-22
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of a drug called AOH1996 for patients with acute myeloid leukemia (AML) that has returned after improvement or has not responded to previous treatments. AOH1996 belongs to a class of medications called PCNA inhibitors, which may help stop cancer cells from growing and damage their DNA. This phase 1 trial aims to find the maximum tolerated dose and study the drug's anti-leukemic effects, including remission rates and survival outcomes. Participants receive AOH1996 orally twice daily on days 1 through 28 of each 28-day cycle. They undergo 2 cycles initially unless the disease progresses or side effects become unacceptable. If patients achieve remission with transfusion independence by the end of cycle 2, they may continue treatment for up to 12 cycles. Throughout the study, bone marrow aspirations and blood sample collections are performed to monitor disease and treatment effects. During the trial, researchers will assess safety by tracking dose-limiting toxicities and adverse events up to 2 years. They will also measure responses such as complete remission, overall survival, progression-free survival, and duration of response for up to 1 or 2 years. Pharmacokinetics of AOH1996 will be studied with blood sampling at specific times. After treatment, participants are followed for safety and outcomes up to one year, with ongoing evaluations to understand treatment impact.
CONDITIONS
Brief Title
A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Life expectancy greater than 3 months
- Diagnosed with relapsed or refractory AML per ICC or WHO criteria
- Patients with extramedullary disease included if bone marrow is involved
- Fully recovered from prior anti-cancer therapy toxic effects except mild alopecia
- Ability to swallow pills
- White blood cell count less than or equal to 25 x 10^9/L before treatment
- Total bilirubin less than or equal to 1.5 times upper limit of normal within 14 days before treatment
- AST and ALT less than or equal to 3 times upper limit of normal within 14 days before treatment
- Creatinine clearance of at least 50 mL/min within 14 days before treatment
- INR or prothrombin time less than or equal to 1.5 times upper limit of normal within 14 days before treatment
- aPTT less than or equal to 1.5 times upper limit of normal within 14 days before treatment
- Corrected QT interval less than or equal to 480 ms within 28 days before treatment
- Negative pregnancy test for women of childbearing potential within 14 days before treatment
- Agreement to use effective birth control or abstain during the study and for 2 months after last dose
You will not qualify if you...
- Hematopoietic stem cell transplant within 100 days before treatment
- Recent chemotherapy, radiation, biologic therapy, or immunotherapy within 14 days before treatment (except hydroxyurea allowed)
- Use of strong CYP enzyme inducers or inhibitors within 14 days before study drug
- Use of foods or supplements that strongly affect CYP3A within 3 days before and during treatment
- Systemic steroid therapy over 10 mg/day prednisone equivalent within 14 days before treatment
- Planning to receive live vaccines during study or 4 weeks before or after
- Diagnosis of blast phase chronic myeloid leukemia
- Acute promyelocytic leukemia or specific translocation t(15;17)
- Active central nervous system disease
- Active graft versus host disease
- Unstable cardiac disease including recent heart attack or uncontrolled arrhythmia or hypertension
- No measurable disease in bone marrow
- Gastrointestinal disorders that impair oral drug absorption
- History of allergic reactions to similar compounds
- Uncontrolled active infection or significant illness
- Other active malignancies interfering with study
- Pregnant or breastfeeding women
- Any condition or situation judged unsafe or incompatible with study procedures
- Inability to comply with study requirements or procedures
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 28 days each
Participants receive AOH1996 orally twice daily on days 1 to 28 of each cycle. Cycles repeat every 28 days for 2 cycles if there is no disease progression or unacceptable toxicity. Participants who achieve remission with transfusion independence by the end of cycle 2 may continue treatment for up to 12 total cycles under the same conditions. Participants also undergo bone marrow aspiration and blood sample collection throughout treatment.
Repeated visits every 28 days for treatment cycles; additional visits for bone marrow aspiration and blood sample collection as scheduled
Duration - Up to 1 year
After completing treatment, participants are followed up to monitor their health and response to treatment for up to one year.
Visits at 30 days post-treatment and periodically up to one year
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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