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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01627132
Recruitment Status : Unknown
Verified June 2012 by Koiti Inokuchi,MD,PhD., Shimousa Hematology Study Group.
Recruitment status was:  Recruiting
First Posted : June 25, 2012
Last Update Posted : June 25, 2012
Sponsor:
Collaborator:
Epidemiological and Clinical Research Information Network
Information provided by (Responsible Party):
Koiti Inokuchi,MD,PhD., Shimousa Hematology Study Group

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Drug: Dasatinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2012
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dasatinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: dasatinib Drug: Dasatinib
100mg QD
Other Name: BMS-354825


Outcome Measures
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Primary Outcome Measures :
  1. The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib. [ Time Frame: at 12 months ]

Secondary Outcome Measures :
  1. Rate of complete molecular remission that will be sustained after dasatinib rechallenge. [ Time Frame: at 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627132


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

Locations
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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
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Principal Investigator: Koiti Inokuchi Nippon Medical School
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Koiti Inokuchi,MD,PhD., Nippon Medical School, Shimousa Hematology Study Group
ClinicalTrials.gov Identifier: NCT01627132    
Other Study ID Numbers: SHSG-01
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
 Hematologic Diseases
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action