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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Kanto CML Study Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Epidemiological and Clinical Research Information Network
Information provided by:
Kanto CML Study Group
ClinicalTrials.gov Identifier:
NCT00866736
First received: March 18, 2009
Last updated: March 7, 2011
Last verified: December 2010
  Purpose

The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.


Condition Intervention Phase
Chronic Myeloid Leukemia
Drug: dasatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Kanto CML Study Group:

Primary Outcome Measures:
  • rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety after treatment with dasatinib [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • rate of Complete Cytogenetic Response(CCyR) [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • rate of Complete Hematologic Response (CHR) [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • efficacy on patients with BCR-ABL point mutations [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dasatinib Drug: dasatinib
100mg QD
Other Name: BMS-354825

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866736

Locations
Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, Japan, 113-8677
Sponsors and Collaborators
Kanto CML Study Group
Epidemiological and Clinical Research Information Network
Investigators
Principal Investigator: Hisashi Sakamaki, MD.PhD Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
  More Information

No publications provided

Responsible Party: Hisashi Sakamaki, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
ClinicalTrials.gov Identifier: NCT00866736     History of Changes
Other Study ID Numbers: KCSG-01
Study First Received: March 18, 2009
Last Updated: March 7, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Kanto CML Study Group:
chronic myeloid leukemia
dasatinib
chronic phase myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib
Dasatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014