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OpenTrials
Completed

NCT Number: NCT00031980

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cyclosporine

Drug

Primary outcomes

  1. Frequency of cytopemic response

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Jan 27, 2003
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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