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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: Recruiting Phase 2 study of Acute Myeloid Leukemia (AML), sponsored by Bio-Path Holdings.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assess whether the combination of BP1001 and Ventoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than Ventoclax + decitabine alone (by historical comparison) with untreated AML that cannot or elect not to be treated with more intensive chemotherapy
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 |
What NCT02781883 shows while recruiting
NCT02781883 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 142-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (24% lower).
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 lists 9 locations in 7 states (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.
Learn More About Clinical Trials
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Where NCT02781883's enrollment target sits among peer trials
108 10th of 29 higher than 20 of 29 other Acute Myeloid Leukemia (AML) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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