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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Shimousa Hematology Study Group
Sponsor:
Collaborator:
Epidemiological and Clinical Research Information Network
Information provided by (Responsible Party):
Koiti Inokuchi,MD,PhD., Shimousa Hematology Study Group
ClinicalTrials.gov Identifier:
NCT01627132
First received: February 14, 2012
Last updated: June 22, 2012
Last verified: June 2012
  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.


Condition Intervention Phase
Chronic Myeloid Leukemia
Drug: Dasatinib
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Shimousa Hematology Study Group:

Primary Outcome Measures:
  • The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib. [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of complete molecular remission that will be sustained after dasatinib rechallenge. [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dasatinib Drug: Dasatinib
100mg QD
Other Name: BMS-354825

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627132

Contacts
Contact: Koiti Inokuchi, MD,PhD +81(0)3-3822-2131 inokuchi@nms.ac.jp

Locations
Japan
Nippon Medical School Recruiting
Sendagi 1-1-5, Bunkyo-ku,Tokyo, Japan, 113-8603
Contact: Koiti Inokuchi, MD,PhD    +81(0)3-3822-2131    inokuchi@nms.ac.jp   
Contact: Hisashi Wakita, MD,PhD    +81(0)476-22-2311    wakita@naritasekijuji.jp   
Principal Investigator: Koiti Inokuchi, MD,PhD         
Sponsors and Collaborators
Shimousa Hematology Study Group
Epidemiological and Clinical Research Information Network
Investigators
Principal Investigator: Koiti Inokuchi Nippon Medical School
  More Information

No publications provided

Responsible Party: Koiti Inokuchi,MD,PhD., Nippon Medical School, Shimousa Hematology Study Group
ClinicalTrials.gov Identifier: NCT01627132     History of Changes
Other Study ID Numbers: SHSG-01
Study First Received: February 14, 2012
Last Updated: June 22, 2012
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Dasatinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014