A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma
- Determine the response rate (complete and partial) in patients with recurrent or
refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.
- Determine the disease-free, progression-free, and overall survival of patients treated
with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of
unacceptable toxicity or disease progression during weeks 1-6. Patients experiencing disease
progression during weeks 7-36, receive an additional 36 weeks of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 2.5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate (Complete and Partial Response)
Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of > 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.
Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up.
Ranjana Advani, MD
United States: Federal Government
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|Rush-Copley Cancer Care Center||Aurora, Illinois 60507|
|Joliet Oncology-Hematology Associates, Limited - West||Joliet, Illinois 60435|
|Carle Cancer Center at Carle Foundation Hospital||Urbana, Illinois 61801|
|Saint Anthony Memorial Health Centers||Michigan City, Indiana 46360|
|Mercy Medical Center - Sioux City||Sioux City, Iowa 51104|
|Siouxland Hematology-Oncology Associates, LLP||Sioux City, Iowa 51101|
|St. Luke's Regional Medical Center||Sioux City, Iowa 51104|
|Bronson Methodist Hospital||Kalamazoo, Michigan 49007|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Borgess Medical Center||Kalamazooaa, Michigan 49001|
|St. Rita's Medical Center||Lima, Ohio 45801|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Hematology Oncology Associates - Skokie||Skokie, Illinois 60076|
|Hematology and Oncology Associates||Chicago, Illinois 60611|
|Midwest Center for Hematology/Oncology||Joliet, Illinois 60432|
|North Shore Oncology and Hematology Associates, Limited - Libertyville||Libertyville, Illinois 60048|
|Stanford Cancer Center||Stanford, California 94305-5824|
|Hematology Oncology Associates of Illinois - Berwyn||Berwyn, Illinois 60402|
|Saint Joseph Hospital||Chicago, Illinois 60657|
|La Grange Oncology Associates - Geneva||Naperville, Illinois 60563|
|Cancer Care and Hematology Specialists of Chicagoland - Niles||Niles, Illinois 60714|