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

NCT02781883 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-03-07

No results posted yet for this study

Summary

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.

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

BP1001 in combination with Ventoclax plus decitabine

BP1001 in combination with Ventoclax plus decitabine

DRUG

BP1001 plus decitabine

BP1001 plus decitabine in ventoclax intolerant or resistant subjects

Sponsors & Collaborators

  • Bio-Path Holdings, Inc.

    lead INDUSTRY

Principal Investigators

  • Maro Ohanian, DO · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02781883 on ClinicalTrials.gov