Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma (NCT00070291) | Clinical Trial Compass
TerminatedPhase 2
Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
Stopped: Slow accrual.
United States4 participantsStarted 2006-01-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Response Rate (Complete and Partial Response)
Timeframe: 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.