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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031980 |
Purpose
RATIONALE: Cyclosporine may improve low blood counts caused by hematologic cancer.
PURPOSE: Phase II trial to study the effectiveness of cyclosporine in treating patients who have low blood counts caused by hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia Leukemia Neutropenia Thrombocytopenia |
Drug: cyclosporine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia |
| Study Start Date: | March 2002 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral cyclosporine every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 months for 1 year and then every 6 months for 9 years.
PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of T-cell large granular lymphocytic leukemia
Patients must have at least 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
| Study Chair: | Maria R. Baer, MD | University of Maryland Greenebaum Cancer Center |
More Information
| Responsible Party: | Cancer and Leukemia Group B ( Richard L. Schilsky ) |
| Study ID Numbers: | CDR0000069246, CALGB-10003 |
| Study First Received: | March 8, 2002 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00031980 History of Changes |
| Health Authority: | Unspecified |
|
stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia |
T-cell large granular lymphocyte leukemia anemia neutropenia thrombocytopenia |
|
Leukemia, Lymphoid Cyclosporine Immunologic Factors Hematologic Neoplasms Large Granular Lymphocyte Leukemia Leukocyte Disorders Granulocytopenia Cyclosporins Leukemia Thrombocytopenia Leukemia, Lymphocytic, Chronic, B-Cell Antifungal Agents Leukemia, B-cell, Chronic Immunoproliferative Disorders |
Hematologic Diseases Blood Platelet Disorders Agranulocytosis Anemia Immunosuppressive Agents Lymphatic Diseases Neutropenia Thrombocytopathy Chronic Lymphocytic Leukemia Leukemia, T-Cell Antirheumatic Agents Lymphoproliferative Disorders Leukopenia Leukemia, Large Granular Lymphocytic |
|
Anti-Infective Agents Leukemia, Lymphoid Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Leukocyte Disorders Cyclosporins Leukemia Thrombocytopenia Therapeutic Uses Antifungal Agents Dermatologic Agents Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Hematologic Diseases Blood Platelet Disorders Anemia Agranulocytosis Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neutropenia Neoplasms Leukemia, T-Cell Antirheumatic Agents Lymphoproliferative Disorders Leukopenia |