Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Cyclosporine in Treating Patients With T-Cell Large Granular Lymphocyte Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Active	Over 18	NCI	NCI-06-C-0177 NCI-P6830, NCT00363779

Special Category: NIH Clinical Center trial

Objectives

Primary

1. Identify changes in gene expression patterns induced by cyclosporine therapy in patients with T-cell large granular lymphocyte leukemia.

Secondary

1. Identify differences between responding and nonresponding patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed T-cell large granular lymphocyte (LGL) leukemia
• Must have hemocytopenia, including ≥ 1 of the following:
  • Granulocyte count < 1,200/mm³
  • Platelet count < 100,000/mm³
  • Hemoglobin < 10 g/dL
  • Transfusion or colony-stimulating factors required to maintain hematopoietic counts
• Measurable or evaluable disease
• Must not have failed prior therapy with cyclosporine for LGL leukemia

Prior/Concurrent Therapy:

• At least 3 weeks since prior cytotoxic chemotherapy
• Concurrent stable-dose corticosteroids allowed
• No other concurrent chemotherapy or investigational anticancer drugs
• No concurrent monoclonal antibodies, gammaglobulin, or drugs that affect lymphocytes

Patient Characteristics:

• Karnofsky performance status 80-100%
• Life expectancy > 3 months
• Creatinine < 2.0 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• No uncontrolled hypertension
• No HIV positivity
• No underlying immunodeficiency
• No hepatitis C antibody positivity or hepatitis B surface antigen positivity
• No serious intercurrent illnesses or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease that would preclude study compliance

Expected Enrollment

A total of 14 patients will be accrued for this study.

Outcomes

Changes in gene expression patterns

Differences of gene expression between responding and nonresponding patients at 12 weeks

Outline

Patients receive oral cyclosporine twice daily. Treatment continues for 3 months followed by a taper in the absence of disease progression or unacceptable toxicity.

Patients undergo apheresis for collection of circulating blood cells at baseline, once steady-state levels of cyclosporine are achieved, and at 6 and 12 weeks after beginning therapy.

Gene expression analysis is performed on pre- and post-treatment samples at baseline and 12 weeks, respectively.

After completion of study treatment, patients are followed at 1 month and then every 3 months thereafter.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

John Janik, MD, Principal investigator		Ph: 301-402-2913 Email: janikj@mail.nih.gov

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Related Information

Web site for additional information

Registry Information
Official Title		Microarray Analysis of the Effect of Cyclosporin Therapy on Gene Expression in Large Granular Lymphocyte (LGL) Leukemia
Trial Start Date		2006-01-01
Trial Completion Date		2010-12-22 (estimated)
Registered in ClinicalTrials.gov		NCT00363779
Date Submitted to PDQ		2006-06-08
Information Last Verified		2009-07-05

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