drugset / Trial / NCT01850004
Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response
Phase 2
Completed
84 enrolled
Bristol-Myers Squibb
European Organisation for Research and Treatment of Cancer - EORTC · collabICON plc · collabMolecular MD · collabMultiPharma · collabPPD Development, LP · collabSteering Committee · collab
NaSingle-groupOpen-labelOther
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.
Timeline
- Start
- 2014-01-22
- Primary completion
- 2017-09-20
- Completion
- 2021-10-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dasatinib anhydrous | Small molecule | 50 mg | Oral |
| Subject | dasatinib anhydrous | Small molecule | 80 mg | Oral |
| Subject | dasatinib anhydrous | Small molecule | 100 mg | Oral |
| Subject | dasatinib anhydrous | Small molecule | 140 mg | Oral |
| Subject | dasatinib anhydrous | Small molecule | 180 mg | Oral |