Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma

Not Applicable

• Conditions: -C844 Peripheral T-cell lymphoma, not classified; Peripheral T-cell lymphoma, not classified; C844

• Registration Number: PER-143-08
• Lead Sponsor: EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-09
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified