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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00039416 |
Purpose
RATIONALE: Imatinib mesylate may stop the growth of myelofibrosis by blocking certain enzymes necessary for cell growth.
PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have myelofibrosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia |
Drug: imatinib mesylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known as STI-571) In Patients With Myelofibrosis |
| Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to Dupriez risk score (low vs intermediate vs high).
Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3-17.5 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed myeloid metaplasia with myelofibrosis (MMM)
All subtypes eligible
Histologically confirmed chronic myelomonocytic leukemia (CMMOL) with t(5;12)(q31;p12) or TEL-platelet-derived growth factor (PDGFR)-beta rearrangement
Meets criteria for 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Evanston Northwestern Health Care - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| La Grange Memorial Hospital | |
| La Grange, Illinois, United States, 60525 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61615-7828 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Michigan | |
| Oncology Care Associates, PLLC | |
| Saint Joseph, Michigan, United States, 49085 | |
| Study Chair: | Olatoyosi M. Odenike, MD | University of Chicago |
More Information
| ClinicalTrials.gov Identifier: | NCT00039416 History of Changes |
| Other Study ID Numbers: | CDR0000069381, UCCRC-11498A, NCI-5669 |
| Study First Received: | June 6, 2002 |
| Last Updated: | February 20, 2010 |
| Health Authority: | United States: Federal Government |
|
polycythemia vera primary myelofibrosis essential thrombocythemia chronic myelomonocytic leukemia |
|
Primary Myelofibrosis Leukemia Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Neoplasms by Histologic Type Neoplasms |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |