Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
Recruitment status was Active, not recruiting
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Initial Treatment With Methotrexate in Large Granular Lymphocytic (LGL) Leukemia|
- Complete, partial, and overall response rates [ Designated as safety issue: No ]
- Clinical response [ Designated as safety issue: No ]
- Toxic effects [ Designated as safety issue: Yes ]
|Study Start Date:||July 1999|
|Estimated Primary Completion Date:||May 2001 (Final data collection date for primary outcome measure)|
- 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.