🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2025-03-07)

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

🟢 Recruiting Phase 2 💊 Investigational Drug / Biologic Sponsor: Bio-Path Holdings, Inc.

🩺 Protocol 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.

Primary Research Facility: UCLA Medical Center (Los Angeles, California)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Acute Myeloid Leukemia (AML)?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged 18 Years or older?

🔍 Protocol Specified Minimum Age: 18 Years

Able to attend required in-person clinic visits and study procedures at one of the participating study centers?

🔍 Logistical Requirement: 9 Registered Participating Sites

📍 Primary Site Map

Site: UCLA Medical Center — Los Angeles, California

📍 All Participating Trial Locations (9 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. UCLA Medical Center — Los Angeles, California • Contact: (310) 528-2565

2. Georgia Cancer Center at Augusta University — Augusta, Georgia • Contact: (706) 721-2505

3. University of Kansas Cancer Center — Fairway, Kansas • Contact: (913) 945-7552

4. New Jersey Hematology Oncology Associates — Brick, New Jersey

5. Laura & Isaac Pe lmutter Cancer Center at NYU Langone Health — New York, New York • Contact: (646) 501-4818

6. Weill Cornell Medical College - New York - Presbyterian Hospital — New York, New York • Contact: (646) 962-2700

7. University of Texas M.D. Anderson Cancer Center — Houston, Texas • Contact: (713) 792-2631

8. Baylor Scott & White Research Institute — Temple, Texas

9. West Virginia University/Mary Babb Randolph Cancer Center — Morgantown, West Virginia

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT02781883 • Last Synced: 2025-03-07

View on ClinicalTrials.gov ↗