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.
Verified June 2012 by Shimousa Hematology Study Group
Sponsor:
Shimousa Hematology Study Group
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
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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
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, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013