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RECRUITING Phase 2

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

NCT02781883 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG BP1001 in combination with Ventoclax plus decitabine
  • DRUG BP1001 plus decitabine

Study Locations (9)

New York

  • Laura & Isaac Pe lmutter Cancer Center at NYU Langone Health — New York
  • Weill Cornell Medical College - New York - Presbyterian Hospital — New York

Texas

  • University of Texas M.D. Anderson Cancer Center — Houston
  • Baylor Scott & White Research Institute — Temple

California

  • UCLA Medical Center — Los Angeles

Georgia

  • Georgia Cancer Center at Augusta University — Augusta

Kansas

  • University of Kansas Cancer Center — Fairway

New Jersey

  • New Jersey Hematology Oncology Associates — Brick

West Virginia

  • West Virginia University/Mary Babb Randolph Cancer Center — Morgantown

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2016-05
Est. Completion 2028-12
Phase Phase 2

Sponsor

Bio-Path Holdings

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02781883

The ClinicalTrials.gov registry entry for NCT02781883 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bio-Path Holdings, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 2 interventions — of which BP1001 in combination with Ventoclax plus decitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02781883 reports 9 study locations spanning 7 distinct geographic areas — top geographies include New York, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02781883 about?

NCT02781883 is a clinical study titled "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\...

What is the current status of trial NCT02781883?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2016-05. Estimated completion is 2028-12.

What conditions does trial NCT02781883 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02781883?

The interventions under investigation include: BP1001 in combination with Ventoclax plus decitabine (DRUG), BP1001 plus decitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02781883?

This trial is sponsored by Bio-Path Holdings, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02781883 being conducted?

This trial has 9 study locations across California, Georgia, Kansas, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial