Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2012
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 14, 2012
CompletedFirst Posted
Study publicly available on registry
June 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJune 25, 2012
June 1, 2012
5 years
February 14, 2012
June 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.
at 12 months
Secondary Outcomes (1)
Rate of complete molecular remission that will be sustained after dasatinib rechallenge.
at 12 months
Study Arms (1)
dasatinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Chronic Myeloid Leukemia in the Chronic Phase.
- Patients with BCR-ABL-negative checks.
- years old over.
- ECOG performance status (PS) score 0-2.
- Adequate organ function (hepatic, renal and lung).
- Signed written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nippon Medical School
Sendagi 1-1-5, Bunkyo-ku,Tokyo, 113-8603, Japan
Related Publications (1)
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.
PMID: 32614159DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Koiti Inokuchi
Nippon Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nippon Medical School
Study Record Dates
First Submitted
February 14, 2012
First Posted
June 25, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2017
Study Completion
January 1, 2019
Last Updated
June 25, 2012
Record last verified: 2012-06