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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
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: | Primary Purpose: 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 | |
| Buffalo, New York, United States, 14263-0001 | |
| Study Chair: | Maria R. Baer, MD | University of Maryland Greenebaum Cancer Center |
More Information
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00031980 History of Changes |
| Other Study ID Numbers: | CDR0000069246, CALGB-10003 |
| Study First Received: | March 8, 2002 |
| Last Updated: | April 24, 2010 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Anemia Leukemia Leukemia, Lymphoid Neutropenia Thrombocytopenia Leukemia, Large Granular Lymphocytic Hematologic Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Agranulocytosis Leukopenia |
Leukocyte Disorders Blood Platelet Disorders Leukemia, T-Cell Cyclosporins Cyclosporine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents |