OncoMatch/Clinical Trials/NCT02781883
Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
Is NCT02781883 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including BP1001 in combination with Ventoclax plus decitabine and BP1001 plus decitabine for acute myeloid leukemia (aml).
Treatment: BP1001 in combination with Ventoclax plus decitabine · BP1001 plus decitabine — The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-cancer therapy
Exception: hydroxyurea or anagrelide (within 24 hours), TKI (within 1 day), a single dose of cytarabine (for proliferative disease)
Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or anagrelide (within 24 hours), TKI (within 1 day), a single dose of cytarabine (for proliferative disease)
Cannot have received: investigational agent or study treatment
Receipt of any investigational agent or study treatment within 30 days prior to C1D1
Lab requirements
Kidney function
eGFR ≥40 ml/min (CKD-Epi, Cockcroft-Gault, MDRD, or 24-hr urine collection)
Liver function
AST and ALT ≤2.5x ULN; total bilirubin ≤1.5x ULN (waiver possible with justification)
Adequate hepatic and renal functions as defined by: AST and ALT ≤2.5x ULN; total bilirubin ≤1.5x ULN (waiver possible); eGFR ≥40 ml/min (CKD-Epi, Cockcroft-Gault, MDRD, or 24-hr urine collection)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Medical Center · Los Angeles, California
- Georgia Cancer Center at Augusta University · Augusta, Georgia
- University of Kansas Cancer Center · Fairway, Kansas
- New Jersey Hematology Oncology Associates · Brick, New Jersey
- Laura & Isaac Pe lmutter Cancer Center at NYU Langone Health · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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