Description:
The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (CMR) while on dasatinib.
The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (CMR) while on dasatinib.
Unknown status
Phase 2
Drug | Synonyms | Arms |
---|---|---|
Dasatinib | BMS-354825 | dasatinib |
Name | Type | Description | Interventions |
---|---|---|---|
dasatinib | Experimental |
|
Inclusion Criteria: - Chronic Myeloid Leukemia in the Chronic Phase. - Patients with BCR-ABL-negative checks. - 15 years old over. - ECOG performance status (PS) score 0-2. - Adequate organ function (hepatic, renal and lung). - Signed written informed consent. Exclusion Criteria: - A case with the double cancer of the activity. - Women who are pregnant or breastfeeding. - Patients with complications or a history of severe. - Patients with mutation of T315I、F317L、V299L. - Patients with additional chromosome abnormalities. - The case of Pleural effusion with poor control. - Patients with a history of hematopoietic stem cell transplantation.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 15 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib. |
Time Frame: | at 12 months |
Safety Issue: | |
Description: |
Measure: | Rate of complete molecular remission that will be sustained after dasatinib rechallenge. |
Time Frame: | at 12 months |
Safety Issue: | |
Description: |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Shimousa Hematology Study Group |
June 25, 2012