NCT00421395

Safety Study of NHL With 90Y-hLL2 IgG

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

90Y-labeled hLL2 will be administered according to a schedule based upon whether or not a patient had prior high-dose chemotherapy with a marrow or stem cell transplant. Patients with both indolent and aggressive types of NHL will be enrolled at each dose level without segregation. However, at the conclusion of the trial, with the maximum tolerated dose (MTD) defined, a minimum number of 6 patients with indolent NHL, 6 patients with aggressive NHL, and 6 patients with \>25% bone marrow involvement will be studied at that dose level.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	90Y-hLL2	weekly dosing for either 2 or 3 weeks

Timeline

• Start date: 2002-08-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2007-01-12
• Last updated: 2021-08-16

Locations

5 sites across 2 countries: France, Germany