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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 (Jun 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 Jun 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

Treatments studied

Other

BP1001 in combination with Ventoclax plus decitabineBP1001 plus decitabine

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 →

Frequently asked questions

Is NCT02781883 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anti-cancer therapy, investigational agent or study treatment disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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