OncoMatch/Clinical Trials/NCT05597306
Venetoclax and Bomedemstat in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Is NCT05597306 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Bomedemstat and Venetoclax for acute myeloid leukemia.
Treatment: Bomedemstat · Venetoclax — This study aims to learn about the safety, tolerability, and different dose levels' safety profiles of Venetoclax and Bomedemstat (VenBom) combination therapy in participants with relapsed or refractory acute myeloid leukemia.
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: standard, front-line therapy
Relapsed/refractory Acute Myeloid Leukemia (AML) following failure of at least one standard, front-line therapy
Cannot have received: investigational products
Exception: hydroxyurea allowed during Cycle 1
Therapy with any investigational products, anti-neoplastic therapy, or radiotherapy within 14 days prior to Cycle 1, Day 1. Exception: Patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea to control the level of circulating leukemic blast counts to not lower than 10,000 cells/μL during Cycle 1 of protocol treatment.
Cannot have received: anti-neoplastic therapy
Exception: hydroxyurea allowed during Cycle 1
Therapy with any investigational products, anti-neoplastic therapy, or radiotherapy within 14 days prior to Cycle 1, Day 1. Exception: Patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea to control the level of circulating leukemic blast counts to not lower than 10,000 cells/μL during Cycle 1 of protocol treatment.
Cannot have received: radiotherapy
Exception: hydroxyurea allowed during Cycle 1
Therapy with any investigational products, anti-neoplastic therapy, or radiotherapy within 14 days prior to Cycle 1, Day 1. Exception: Patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea to control the level of circulating leukemic blast counts to not lower than 10,000 cells/μL during Cycle 1 of protocol treatment.
Lab requirements
Blood counts
Hemoglobin > 8 g/dL (transfusion allowed); WBC < 25,000/μL before Cycle 1 Day 1 (hydroxyurea allowed during Cycle 1); Platelet count ≥ 20,000/μL before Cycle 1 Day 1 (transfusion allowed)
Kidney function
Calculated creatinine clearance > 50 ml/min
Liver function
Total bilirubin ≤ 2 ULN except Gilbert's syndrome; ALT and AST ≤ 3 × ULN
Total bilirubin ≤ 2 ULN except in patients with Gilbert's syndrome. ALT and AST ≤ 3 × ULN. Calculated creatinine clearance > 50 ml/min. Hemoglobin > 8 g/dL (prior RBC transfusion allowed). WBC < 25,000 cells/μL before administration of VenBom on Cycle 1 Day 1. Platelet count ≥ 20,000 cells/μL before administration of VenBom on Cycle 1 Day 1.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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