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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00110097 |
RATIONALE: BMS-354825 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well BMS-354825 works in treating patients with blastic phase chronic myelogenous leukemia or acute lymphoblastic leukemia that did not respond to previous imatinib mesylate.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: dasatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of BMS-354825 in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate |
Study Start Date: | January 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive oral BMS-354825 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 2 weeks for the first 3 courses, monthly thereafter during study treatment, and 30 days after completion of study treatment.
After completion of study treatment, patients are followed for at least 30 days.
PROJECTED ACCRUAL: A minimum of 60 patients (at least 30 with blastic phase chronic myelogenous leukemia and at least 30 with acute lymphoblastic leukemia) will be accrued for this study within 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Blastic phase chronic myelogenous leukemia (CML), meeting ≥ 1 of the following criteria:
Acute lymphoblastic leukemia (ALL)
Previously treated with imatinib mesylate AND meets 1 of the following criteria:
Primary* or acquired** hematologic resistance to imatinib mesylate, defined as 1 of the following:
NOTE: **Disease responded to treatment with imatinib mesylate but subsequently progressed to blastic phase CML
Intolerant to imatinib mesylate, defined as toxicity possibly related to treatment with imatinib mesylate at a dose ≤ 400 mg/day that led to discontinuation of therapy
Patients who tolerated a dose of imatinib mesylate at 400 mg/day but are intolerant to higher doses are not considered intolerant to imatinib mesylate NOTE: *Imatinib mesylate need not be the most recent treatment for CML or ALL prior to study entry
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
No history of significant bleeding disorder unrelated to CML, including any of the following:
Hepatic
Renal
Cardiovascular
No history of second or third degree heart block
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 5 days or 5 half-lives (whichever is longer) since prior and no concurrent drugs that may confer a risk of torsades de pointes, including any of the following:
At least 5 days or 5 half-lives (whichever is longer) since prior and no concurrent medications that directly inhibit platelet function (except anagrelide for treatment of thrombocytosis due to CML), including any of the following:
At least 5 days or 5 half-lives (whichever is longer) since prior and no concurrent anticoagulants (e.g., warfarin or heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin])
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 |
Study Chair: | Neil P. Shah, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000422432, UCLA-0411071-01, BMS-CA180015, EUDRACT-2004-002517-36 |
Study First Received: | May 3, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00110097 History of Changes |
Health Authority: | United States: Federal Government |
blastic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia relapsing chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia |
Philadelphia Chromosome Blast Crisis Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Protein Kinase Inhibitors Recurrence Imatinib |
Lymphatic Diseases Leukemia Dasatinib Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chromosome Aberrations Chronic Myelogenous Leukemia Lymphoproliferative Disorders Bone Marrow Diseases Lymphoma Acute Lymphoblastic Leukemia |
Philadelphia Chromosome Blast Crisis Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Protein Kinase Inhibitors Leukemia Neoplastic Processes Pathologic Processes Therapeutic Uses Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases |
Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Pharmacologic Actions Translocation, Genetic Imatinib Lymphatic Diseases Neoplasms Chromosome Aberrations Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Lymphoproliferative Disorders Cell Transformation, Neoplastic |