Trials / Completed
CompletedNCT01850004
Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response
Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Primary Purpose: Protocol designed to evaluate remission of disease after treatment discontinuation. Treatment re-started if relapse occurs
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dasatinib |
Timeline
- Start date
- 2014-01-22
- Primary completion
- 2017-09-20
- Completion
- 2021-10-08
- First posted
- 2013-05-09
- Last updated
- 2022-11-03
- Results posted
- 2018-11-02
Locations
28 sites across 6 countries: United States, Canada, France, Germany, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01850004. Inclusion in this directory is not an endorsement.