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


Phase 2
15 Years
N/A
Open (Enrolling)
Both
Chronic Myeloid Leukemia

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

at 12 months

Safety Issue:

No

Principal Investigator

Koiti Inokuchi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nippon Medical School

Authority:

Japan: Institutional Review Board

Study ID:

SHSG-01

NCT ID:

NCT01627132

Start Date:

February 2012

Completion Date:

January 2019

Related Keywords:

  • Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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