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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00702403 |
RATIONALE: Imatinib mesylate and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects of nilotinib when given together with or without imatinib mesylate and to see how well they work when given after donor stem cell transplant in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: imatinib mesylate Drug: nilotinib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multicenter Phase I/II Study of the Prophylactic Inhibition of BCR-ABL Tyrosine Kinase by Tasigna ® (Nilotinib) After Hematopoietic Cell Transplantation for Philadelphia Chromosome-Positive Leukemias |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Imatinib mesylate-sensitive leukemia: Experimental
Patients receive oral imatinib mesylate once daily beginning on the day of engraftment (between 21 and 42 days after transplant) and continuing until day 80. Patients then receive oral nilotinib twice daily on days 81-445 in the absence of disease progression or unacceptable toxicity.
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Drug: imatinib mesylate
Given orally
Drug: nilotinib
Given orally
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Imatinib mesylate-resistant leukemia: Experimental
Patients receive oral nilotinib twice daily beginning on the day of engraftment (between 21 and 42 days after transplant) and continuing until day 445 in the absence of disease progression or unacceptable toxicity.
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Drug: nilotinib
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo standard conditioning therapy followed by allogeneic hematopoietic stem cell transplantation on day 0. Patients proceed to further therapy based on known response to imatinib mesylate (sensitive or resistant).
Bone marrow and blood samples are collected periodically for laboratory studies. Samples are analyzed by PCR for quantitative levels of the BCR/ABL gene.
Pharmacokinetic and flow cytometry studies are also performed.
After completion of study treatment, patients are followed periodically.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
No known T315I mutation
No aberrant antigen expression on ≥ 5% of marrow leukemic blasts by multidimensional flow cytometric assay immediately before conditioning therapy
Planning to undergo allogeneic hematopoietic stem cell transplantation
No CNS involvement with leukemia
PATIENT CHARACTERISTICS:
Life expectancy ≥ 2 months
No impaired cardiac function, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Paul Carpenter, MD 206-667-3786 |
Principal Investigator: | Paul Carpenter, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Paul Carpenter ) |
Study ID Numbers: | CDR0000597945, FHCRC-2223.00, FHCRC-IR-6691, NOVARTIS-FHCRC-2223.00 |
Study First Received: | June 19, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00702403 History of Changes |
Health Authority: | Unspecified |
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia Philadelphia chromosome positive childhood precursor acute lymphoblastic leukemia Philadelphia chromosome positive chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia |
childhood chronic myelogenous leukemia chronic phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission childhood acute lymphoblastic leukemia in remission |
Acute Lymphoblastic Leukemia, Childhood Philadelphia Chromosome Blast Crisis Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Protein Kinase Inhibitors |
Imatinib Leukemia Lymphatic Diseases Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chromosome Aberrations Chronic Myelogenous Leukemia Bone Marrow Diseases Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia |
Philadelphia Chromosome Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Protein Kinase Inhibitors Leukemia Pathologic Processes Therapeutic Uses Immunoproliferative Disorders Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Hematologic Diseases |
Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Translocation, Genetic Pharmacologic Actions Imatinib Lymphatic Diseases Neoplasms Chromosome Aberrations Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoproliferative Disorders Bone Marrow Diseases |