A Phase I Clinical Trial of Radiolabeled Immunotherapy With Humanized LL2 in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma

Gilead Sciences2 个研究点分布在 1 个国家目标入组 27 人开始时间: 2003年3月最近更新: 2021年8月16日

适应症

试验速览

The purpose of this trial is to determine the safety of 90Y-hLL2 at different dose levels in the treatment of Non-Hodgkin's lymphoma.

•Age Range: Male or Female at least 18 years of age
•Performance Status: Patients with a Karnofsky performance status > 60% (or equivalent, ECOG 0-2) and expected survival of at least 12 weeks.
•Hematopoietic: Hemoglobin > 10 g/dL; ANC > 1.5x10^9/L; Platelets > 100x10^9/L;
•Hepatic: Serum bilirubin < 2.0 mg/dL; AST and ALT < 2 x ULN w/o liver metastases or <5 x ULN w/liver metastases
•Renal: Creatinine < 2.0 mg/dL
•Cardiovascular: Patients with LVEF >/= 50% by MUGA or 2D-ECHO.
•Pulmonary: Patients with DFCO and FEV1 >/= 60% by required Pulmonary Function Tests.
•Other: Patients agreeing to use a medically effective method of contraception while enrolled in the study. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.

发起方

申办方类型

Industry

Loading locations...