Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of methotrexate with or without cyclophosphamide in treating patients who have lymphocytic leukemia with neutropenia or anemia.

Further Study Information

OBJECTIVES:

• Determine the complete, partial, and overall response rates to methotrexate in patients with large granular lymphocytic (LGL) leukemia presenting with neutropenia or anemia.

• Determine the complete, partial, and overall response rates to cyclophosphamide in the patients who fail to respond to methotrexate.

• Assess the association of clinical response with increased sensitivity of leukemic LGL to Fas-dependent apoptosis, reduction in levels of Fas ligand, and disappearance of leukemic clone.

• Determine the toxic effects of methotrexate and cyclophosphamide in these patients.

OUTLINE: Patients are stratified according to symptom (neutropenia vs anemia).

Patients receive oral methotrexate once a week for 4 months and oral prednisone daily for 54 days. Patients who show a partial response to methotrexate may continue this therapy for up to 1 year. Patients who do not respond to this therapy after 4 months then receive oral cyclophosphamide daily for up to 1 year and oral prednisone daily for 54 days.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 38-88 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Cytologically proven T-cell large granular lymphocytic (LGL) leukemia

• Absolute LGL count greater than 500/mm3 (peripheral blood only)

• CD3+ and CD57+ cells greater than 400/mm3 OR

• CD8+ cells greater than 650/mm3

• Clonal T-cell receptor gene rearrangement

• At least 1 of the following:

• Severe neutropenia (neutrophil count less than 500/mm3)

• Neutropenia associated with recurrent infections

• Symptomatic anemia

• Transfusion dependent anemia

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 2 years

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• SGOT no greater than 1.5 times normal

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior or concurrent malignancy within past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix

• No other serious medical illness

• No concurrent psychiatric condition

PRIOR CONCURRENT THERAPY:

• No prior oral methotrexate or cyclophosphamide

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Thomas Patrick Loughran

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003910
Information obtained from ClinicalTrials.gov on December 14, 2011

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