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

Shimousa Hematology Study Group

Status and phase: Unknown; Phase 2

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Dasatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT01627132

SHSG-01

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

dasatinib

Experimental group

Treatment:

Drug: Dasatinib