A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma

EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),0 个研究点目标入组 0 人开始时间: 2009年3月9日最近更新: 2023年9月4日

试验速览

暂无简介。

•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.

•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.

发起方

EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),