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Completed

NCT Number: NCT00866736

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

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.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Bunkyo-ku, Tokyo, 113-8677, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Written Informed Consent
  • Subjects with chronic phase chronic myeloid leukemia (CML)
  • Subjects resistant/intolerant to imatinib
  • Subjects presenting:
  • ECOG performance status (PS) score 0-2
  • Adequate hepatic function
  • Adequate renal function
  • 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

Treatment and study plan

dasatinib

Drug

100mg QD

Other names: BMS-354825

Primary outcomes

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

    Time frame: at 12 months

Secondary outcomes

  1. safety after treatment with dasatinib

    Time frame: 2 year

  2. rate of Complete Cytogenetic Response(CCyR)

    Time frame: 2 year

  3. rate of Complete Hematologic Response (CHR)

    Time frame: 2 year

  4. efficacy on patients with BCR-ABL point mutations

    Time frame: 2 year

  5. progression free survival

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

Kanto CML Study Group

Other

Collaborators

  • Epidemiological and Clinical Research Information Network

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 20, 2009
Registry last updated
Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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