Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shimousa Hematology Study Group
• Collaborator: Epidemiological and Clinical Research Information Network
• Treatments: Dasatinib

Criteria

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.