Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer
This study has been completed.
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00031980
First received: March 8, 2002
Last updated: April 24, 2010
Last verified: May 2008
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
cyclic neutropenia
Drug Information available for:
Cyclosporine
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Frequency of cytopemic response [ Designated as safety issue: No ]
| Study Start Date: | March 2002 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the frequency of cytopenic response in patients with T-cell large granular lymphocytic leukemia treated with cyclosporine.
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 |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of T-cell large granular lymphocytic leukemia
- Increased numbers of large granular lymphocytes in peripheral blood smears
- CD3+CD8+CD57+ immunophenotype by flow cytometry AND
- CD3+CD57+ cell count at least 2,000/mm^3 OR
- CD3+CD57+ cell count at least 500/mm^3 with clonal T-cell receptor beta gene rearrangement
Patients must have at least 1 of the following:
- Severe neutropenia (absolute neutrophil count (ANC) less than 500/mm^3)
- Neutropenia (ANC less than 1,000/mm^3) and recurrent infections
- Anemia (hemoglobin less than 9 g/dL)
- Thrombocytopenia (platelet count less than 50,000/mm^3)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- NCI CTC 0-3
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 2 times ULN
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)
- No concurrent dexamethasone or other steroidal antiemetics
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No prior cyclosporine therapy for this leukemia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031980
Locations
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
| Study Chair: | Maria R. Baer, MD | University of Maryland Greenebaum Cancer Center |
More Information
Additional Information:
No publications provided
| 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 |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013