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

Chronic Myeloid Leukemia Clinical 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 Details — Status: Recruiting

Administrative data

• NCT number: NCT01627132
• Other study ID #: SHSG-01
• Status: Recruiting
• Phase: Phase 2
• First received: February 14, 2012
• Last updated: June 22, 2012
• Start date: February 2012
• Est. completion date: January 2019

Study information

• Verified date: June 2012
• Source: Shimousa Hematology Study Group
• Contact: Koiti Inokuchi, MD,PhD
• Phone: +81(0)3-3822-2131
• Email: inokuchi[@]nms.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2019
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Dasatinib
100mg QD

Locations

Country	Name	City	State
Japan	Nippon Medical School	Sendagi 1-1-5	Bunkyo-ku,Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Shimousa Hematology Study Group	Epidemiological and Clinical Research Information Network

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.		at 12 months	No
Secondary	Rate of complete molecular remission that will be sustained after dasatinib rechallenge.		at 12 months	No