Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized IMMU-LL2: Treatment With 90Y-hLL2 IgG

NCT00421395 Phase 1/Phase 2 COMPLETED

This will be an open label, multiple center, non-randomized, dose-escalation Phase I/II trial, designed to evaluate the safety and effectiveness of a repeated, outpatient regimen utilizing IMMU-hLL2 intact monoclonal antibody IgG labeled with different doses of 90Y for the treatment of patients B-cell lymphoma (NHL).

Details

Lead sponsor	Gilead Sciences
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	59
Start date	2002-08
Completion	2007-10

Conditions

• NHL
• B-cell NHL
• Non-Hodgkins Lymphoma

Interventions

• 90Y-hLL2

Primary outcomes

• Safety will be evaluated from physical examinations, hematology and chemistry testing and toxicity evaluation — First 12 weeks, total 5 years

Countries

France, Germany