OncoMatch/Clinical Trials/NCT06763341
A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Is NCT06763341 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Azacitidine and PCNA Inhibitor AOH1996 for recurrent acute myeloid leukemia.
Treatment: Azacitidine · PCNA Inhibitor AOH1996 · Venetoclax — This phase 1 trial tests safety, side effects, and best dose of AOH1996 for the treatment of patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or AML that has not responded to previous treatment (refractory). AOH1996 is in a class of medications called PCNA inhibitors. It inhibits cancer growth and induces deoxyribonucleic acid (DNA) damage. This may help keep cancer cells from growing and damage cancer cell DNA. Giving AOH1996 may be safe, tolerable and/or effective in treating patients with AML.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: any available therapy known to be effective for AML
who have failed treatment with, or are ineligible for, available therapies known to be effective for treatment of their AML
Cannot have received: hematopoietic stem cell transplant
Exception: allowed if >100 days prior to day 1 of protocol therapy and off calcineurin inhibitors for at least 2 weeks
Hematopoietic stem cell transplant within 100 days prior to day 1 of protocol therapy. Patients who have stopped calcineurin inhibitors (CNI) must be off CNIs for at least 2 weeks prior to day 1 of protocol therapy
Cannot have received: chemotherapy
Exception: hydroxyurea allowed prior to treatment and through cycle 1 for control of rapidly progressing leukemia
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy with the following exception of hydroxyurea which is allowed prior to treatment and through cycle 1 for control of rapidly progressing leukemia
Cannot have received: radiation therapy
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Cannot have received: biological therapy
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Cannot have received: immunotherapy
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Lab requirements
Blood counts
White blood cell (WBC) ≤ 25 x 10^9/L prior to initiation of study therapy; INR or PT ≤ 1.5 x ULN; aPTT ≤ 1.5 x ULN
Kidney function
Creatinine clearance of ≥ 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 X upper limit of normal (ULN); AST ≤ 3.0 x ULN; ALT ≤ 3.0 x ULN
Cardiac function
Corrected QT interval (QTc)F ≤ 480 ms based on Fridericia's formula; unstable cardiac disease as defined by recent MI (within 6 months), uncontrolled atrial fibrillation or hypertension [excluded]
Total bilirubin ≤ 1.5 X upper limit of normal (ULN); AST ≤ 3.0 x ULN; ALT ≤ 3.0 x ULN; Creatinine clearance of ≥ 50 mL/min; INR or PT ≤ 1.5 x ULN; aPTT ≤ 1.5 x ULN; QTcF ≤ 480 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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