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NCT02781883 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
A Phase 2 study of Acute Myeloid Leukemia (AML), sponsored by Bio-Path Holdings.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
- 9
- Study locations
NCT02781883 is a Phase 2 study of Acute Myeloid Leukemia (AML) that is actively recruiting participants, run by Bio-Path Holdings. The registered enrollment target is 108 participants, below the 142-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (24% lower). The trial reports 9 study locations across 7 states.
The verdict
NCT02781883, a Phase 2 study of Acute Myeloid Leukemia (AML), is actively recruiting participants, sponsored by Bio-Path Holdings.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
- 9
- Study locations
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2016-05 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 142-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (24% lower). The listed sponsor is Bio-Path Holdings, which has 5 total studies on file at ClinicalTrials.gov.
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.
NCT02781883 reports 9 study locations spanning 7 distinct geographic areas - top geographies include New York, Texas, California.
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).
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).
Who is sponsoring clinical trial NCT02781883?
This trial is sponsored by Bio-Path Holdings, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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