A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate

The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.

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Key information

Conditions

Leukemia, Myeloid, Chronic Blast Crisis Bone Marrow Diseases Carcinogenesis Cell Transformation, Neoplastic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphocytic, Acute, L2 Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Lymphatic Diseases Lymphoproliferative Disorders Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosis of accelerated phase or blast phase CML or Ph+ ALL
Intolerant or resistant to imatinib mesylate
18 years of age or older
ECOG performance 0-2 (greater than 50% of time out of bed)
Adequate liver and kidney function

Exclusion criteria

Pregnant or breastfeeding females
History of significant cardiac disease
History of significant bleeding disorder (not CML)
Prisoners

Treatment and study plan

dasatinib

Drug

Tablets, Oral, 70 mg, Twice daily, 2 months.

Other names: Sprycel

Primary outcomes

Provide therapy to patients for which there is no therapeutic alternative

Secondary outcomes

Safety data collection

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Study of Dasatinib (BMS-354825) in Subjects With Chronic Myelogenous Leukemia With Accelerated or Myeloid or Lymphoid Blast Phase or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant to or Intolerant of Imatinib Mesylate

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Mar 6, 2006
Registry last updated: Feb 8, 2010

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.

Published trials that share one or more normalized conditions with this study.

Completed