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

NCT ID: NCT01627132

Last Updated: 2012-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dasatinib

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

100mg QD

Interventions

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Dasatinib

100mg QD

Intervention Type DRUG

Other Intervention Names

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BMS-354825

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Epidemiological and Clinical Research Information Network

OTHER

Sponsor Role collaborator

Shimousa Hematology Study Group

OTHER

Sponsor Role lead

Responsible Party

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Koiti Inokuchi,MD,PhD.

Nippon Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Koiti Inokuchi

Role: PRINCIPAL_INVESTIGATOR

Nippon Medical School

Locations

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Nippon Medical School

Sendagi 1-1-5, Bunkyo-ku,Tokyo, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Koiti Inokuchi, MD,PhD

Role: CONTACT

+81(0)3-3822-2131

Facility Contacts

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Koiti Inokuchi, MD,PhD

Role: primary

+81(0)3-3822-2131

Hisashi Wakita, MD,PhD

Role: backup

+81(0)476-22-2311

References

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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.

Reference Type DERIVED
PMID: 32614159 (View on PubMed)

Other Identifiers

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SHSG-01

Identifier Type: -

Identifier Source: org_study_id

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