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

Gilead Sciences2 sites in 1 country27 target enrollmentMarch 2003

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2003

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•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.