Non Hodgkin Lymphoma Clinical Trial
Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
Summary
RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma.
PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.
Full Description
OBJECTIVES:
Primary
Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.
Secondary
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.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination.
At least one objective measurable or evaluable disease parameter.
Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. Patients may not receive concurrent chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Adequate renal function as indicated by creatinine <= 1.5 the upper limit of normal (ULN).
Adequate liver function as indicated by alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 2x the upper limit of normal.
Total bilirubin <= 2x the upper limit of normal.
Age 18 or older.
Exclusion Criteria:
Prior cyclosporine or Tacrolimus (FK506).
Prior allogeneic transplant.
Evidence of active infection.
Congestive heart failure, kidney failure, liver failure, or other severe co-morbidities.
Evidence of active neurological impairment.
Previous history of hypersensitivity to cyclosporine and/or Cremorphor EL (polyoxyethylated oil).
History of other malignancies (other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin).
pregnant or breastfeeding women.
Human immunodeficiency virus (HIV) positive.
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There are 19 Locations for this study
Stanford California, 94305, United States
Aurora Illinois, 60504, United States
Berwyn Illinois, 60402, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60657, United States
Joliet Illinois, 60432, United States
Joliet Illinois, 60435, United States
Libertyville Illinois, 60048, United States
Naperville Illinois, 60563, United States
Niles Illinois, 60714, United States
Skokie Illinois, 60076, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Michigan City Indiana, 46360, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
Baltimore Maryland, 21231, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Lima Ohio, 45801, United States
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