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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).

Phase 2RecruitingBio-Path Holdings, Inc.NCT02781883Data as of May 2026

Treatment: BP1001 in combination with Ventoclax plus decitabine · BP1001 plus decitabineThe 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.

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Extracted 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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