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A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia


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

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Trial Information

A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia


Inclusion Criteria:



- Signed Written Informed Consent

- Subjects with chronic phase chronic myeloid leukemia (CML)

- Subjects resistant/intolerant to imatinib

- Subjects presenting:

1. ECOG performance status (PS) score 0-2

2. Adequate hepatic function

3. Adequate renal function

4. Adequate lung function

Exclusion Criteria:

- Concurrent malignancy other than CML

- Women who are pregnant or breastfeeding

- Concurrent pleural effusion

- Uncontrolled or significant cardiovascular disease

- A serious uncontrolled medical disorder that would impair the ability of the subjects
to receive protocol therapy.

- Prior therapy with dasatinib

- Subjects with T315I and/or F317L BCR-ABL point mutations

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects

Outcome Time Frame:

at 12 months

Safety Issue:

No

Principal Investigator

Hisashi Sakamaki, MD.PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Authority:

Japan: Institutional Review Board

Study ID:

KCSG-01

NCT ID:

NCT00866736

Start Date:

March 2009

Completion Date:

October 2013

Related Keywords:

  • Chronic Myeloid Leukemia
  • chronic myeloid leukemia
  • dasatinib
  • chronic phase myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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