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Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00031980
First Posted: January 27, 2003
Last Update Posted: July 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Frequency of cytopemic response [ Time Frame: Up to 10 years ]

Enrollment: 30
Study Start Date: March 2002
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cyclosporine

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.

Drug: cyclosporine

Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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:

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

Other:

  • No prior cyclosporine therapy for this leukemia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031980


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Maria R. Baer, MD University of Maryland Greenebaum Cancer Center
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00031980     History of Changes
Other Study ID Numbers: CALGB-10003
CDR0000069246 ( Registry Identifier: NCI Physician Data Query )
First Submitted: March 8, 2002
First Posted: January 27, 2003
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
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:
Leukemia
Leukemia, Lymphoid
Thrombocytopenia
Neutropenia
Leukemia, Large Granular Lymphocytic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Blood Platelet Disorders
Hematologic Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Leukemia, T-Cell
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors