Clinical Trials /

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

NCT01627132

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.

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
  • Official Title: Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial

Clinical Trial IDs

  • ORG STUDY ID: SHSG-01
  • NCT ID: NCT01627132

Conditions

  • Chronic Myeloid Leukemia

Interventions

DrugSynonymsArms
DasatinibBMS-354825dasatinib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
dasatinibExperimental
  • Dasatinib

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:15 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.
Time Frame:at 12 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Rate of complete molecular remission that will be sustained after dasatinib rechallenge.
Time Frame:at 12 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Shimousa Hematology Study Group

Last Updated

June 22, 2012