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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 |
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 |
Chromosomal abnormalities Philadelphia Chromosome Blast Crisis Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Chronic myelogenous leukemia Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Recurrence |
Acute lymphoblastic leukemia, adult Imatinib Lymphatic Diseases Leukemia Dasatinib Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chromosome Aberrations Lymphoproliferative Disorders Bone Marrow Diseases Lymphoma |
Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Translocation, Genetic |
Pharmacologic Actions Neoplasms Neoplastic Processes Pathologic Processes Therapeutic Uses Cell Transformation, Neoplastic |