Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML

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 compa

Trial Details

NCT ID
NCT02781883
Phase
PHASE2
Sponsor
Bio-Path Holdings, Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • BP1001 in combination with Ventoclax plus decitabine
  • BP1001 plus decitabine
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Augusta, Georgia, United States|33.47097,-81.97484
  • Fairway, Kansas, United States|39.02223,-94.6319
  • Brick, New Jersey, United States|40.05928,-74.13708
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • At the time of Screening, participants must meet all of the following criteria to be considered eligible to participate in the study:
  • Adults ≥18 years of age
  • Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study a…
  • Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or decitabine

For full eligibility, visit ClinicalTrials.gov.

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