None listed
Conditions
Interventions
Cyclosporine Type of group
Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6, starting dose will begin at cyclosporine 3 mg/kg by mouth two times a day (PO BID)) and 150-250 ng/mL during the maintenance period (weeks 7-36, maintenance dose will begin at cyclosporine 2 mg/kg PO BID) in the absence of renal toxicity
Sponsors
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkins 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. Measure:Response Rate (Complete and Partial Response) Timepoints: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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Overall survival was defined as time from randomization to death from any cause. Measure:Overall Survival Timepoints:Assessed every 3 months for 2 years, then every 6 months for 1 year. | — |
Countries
Peru, United States
Outcome results
None listed