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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2008

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

MedlinePlus related topics:   Anemia    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

ChemIDplus related topics:   Cyclosporine    Cyclosporin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care
Official Title:   Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Frequency of cytopemic response

Study Start Date:   March 2002
Primary Completion Date:   May 2005 (Final data collection date for primary outcome measure)

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
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     Recruiting
      Buffalo, New York, United States, 14263-0001
      Contact: Clinical Trials Office - Roswell Park Cancer Institute     877-275-7724        

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)

Investigators
Study Chair:     Maria R. Baer, MD     University of Maryland Greenebaum Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000069246, CALGB-10003
First Received:   March 8, 2002
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00031980
Health Authority:   Unspecified

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

Study placed in the following topic categories:
Leukemia, Lymphoid
Cyclosporine
Hematologic Neoplasms
Clotrimazole
Miconazole
Leukocyte Disorders
Granulocytopenia
Cyclosporins
Leukemia
Thrombocytopenia
Chronic lymphocytic leukemia
Large granular lymphocyte leukemia
Immunoproliferative Disorders
Hematologic Diseases
Blood Platelet Disorders
Tioconazole
Agranulocytosis
Anemia
Lymphatic Diseases
Neutropenia
Thrombocytopathy
Leukemia, T-Cell
Lymphoproliferative Disorders
Leukemia, B-Cell
Leukopenia
Leukemia, Large Granular Lymphocytic

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 07, 2008




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