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NCT01850004 · ClinicalTrials.gov registry record · Phase 2
Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response
A Phase 2 study of Chronic Phase Chronic Myeloid Leukemia, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT01850004: Completed Phase 2 study of Chronic Phase Chronic Myeloid Leukemia, sponsored by Bristol-Myers Squibb.
NCT01850004 is a Phase 2 study of Chronic Phase Chronic Myeloid Leukemia that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01850004, a Phase 2 study of Chronic Phase Chronic Myeloid Leukemia, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL residual disease.
Primary Outcome
Major Molecular Response (MMR) rate at 12 months is the percentage of participants who maintain MMR (BCR-ABL transcripts \< 0.1% on the International Scale \[IS\]) at 12 months after Dasatinib discontinuation without restarting Dasatinib
Conditions Studied
Interventions
- DRUG Dasatinib
Study Locations (20)
Other
- Local Institution - 0012 - Paris
- Local Institution - 0003 - Pessac
- Local Institution - 0030 - Pierre-Bénite
- Local Institution - 0002 - Vandœuvre-lès-Nancy
- Local Institution - 0026 - Aachen
- Local Institution - 0020 - Berlin
- Local Institution - 0021 - Mannheim
- Local Institution - 0022 - Ulm
- Local Institution - 0025 - Catania
- Local Institution - 0017 - Florence
California
- Local Institution - 0006 - Duarte
- Local Institution - 0029 - Los Angeles
- Local Institution - 0001 - San Franisco
Texas
- Local Institution - 0011 - Dallas
- Local Institution - 0023 - Houston
Illinois
- Local Institution - 0013 - Chicago
New Jersey
- Local Institution - 0024 - Hackensack
New York
- Local Institution - 0028 - New York
Ontario
- Local Institution - 0005 - Toronto
Mecklenburg-Vorpommern
- Local Institution - 0019 - Rostock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2014-01-22 |
| Est. Completion | 2021-10-08 |
| Phase | Phase 2 |
What the finished NCT01850004 record still lists
NCT01850004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Chronic Phase Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Dasatinib is the first listed.
NCT01850004 names 20 study sites across 8 states, led by Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT01850004 about?
NCT01850004 is a clinical study titled "Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response". The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL r...
What is the current status of trial NCT01850004?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2014-01-22. Estimated completion is 2021-10-08.
What conditions does trial NCT01850004 study?
This clinical trial studies the following conditions: Chronic Phase Chronic Myeloid Leukemia.
What interventions are being tested in trial NCT01850004?
The interventions under investigation include: Dasatinib (DRUG).
Who is sponsoring clinical trial NCT01850004?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01850004 being conducted?
This trial has 20 study locations across California, Illinois, New Jersey, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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