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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

Primary Purpose

Chronic Myeloid Leukemia

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
Shimousa Hematology Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nippon Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dasatinib

Arm Description

Outcomes

Primary Outcome Measures

The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.

Secondary Outcome Measures

Rate of complete molecular remission that will be sustained after dasatinib rechallenge.

Full Information

First Posted
February 14, 2012
Last Updated
June 22, 2012
Sponsor
Shimousa Hematology Study Group
Collaborators
Epidemiological and Clinical Research Information Network
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1. Study Identification

Unique Protocol Identification Number
NCT01627132
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shimousa Hematology Study Group
Collaborators
Epidemiological and Clinical Research Information Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dasatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
BMS-354825
Intervention Description
100mg QD
Primary Outcome Measure Information:
Title
The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Rate of complete molecular remission that will be sustained after dasatinib rechallenge.
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koiti Inokuchi, MD,PhD
Phone
+81(0)3-3822-2131
Email
inokuchi@nms.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koiti Inokuchi
Organizational Affiliation
Nippon Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nippon Medical School
City
Sendagi 1-1-5
State/Province
Bunkyo-ku,Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koiti Inokuchi, MD,PhD
Phone
+81(0)3-3822-2131
Email
inokuchi@nms.ac.jp
First Name & Middle Initial & Last Name & Degree
Hisashi Wakita, MD,PhD
Phone
+81(0)476-22-2311
Email
wakita@naritasekijuji.jp
First Name & Middle Initial & Last Name & Degree
Koiti Inokuchi, MD,PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32614159
Citation
Kumagai T, Nakaseko C, Nishiwaki K, Yoshida C, Ohashi K, Takezako N, Takano H, Kouzai Y, Murase T, Matsue K, Morita S, Sakamoto J, Wakita H, Sakamaki H, Inokuchi K; Kanto CML, Shimousa Hematology Study Groups. Silent NK/T cell reactions to dasatinib during sustained deep molecular response before cessation are associated with longer treatment-free remission. Cancer Sci. 2020 Aug;111(8):2923-2934. doi: 10.1111/cas.14518. Epub 2020 Jun 26.
Results Reference
derived

Learn more about this trial

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

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