Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma

Phase 3

• Conditions: Lymphoma

• Registration Number: NCT00003337
• Lead Sponsor: Gilead Sciences

Brief Summary

RATIONALE: Diagnostic imaging procedures using radiolabeled monoclonal antibodies may improve the ability to detect and stage non-Hodgkin's lymphoma.

PURPOSE: Phase III trial to study the effectiveness of a radiolabeled monoclonal antibody in the detection and staging of patients with non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES: I. Determine the radioimmunodetection performance of the imaging agent technetium Tc 99m LL2 monoclonal antibody (LymphoScan) in patients with low, intermediate, and high grade B-cell non-Hodgkin's lymphoma. II. Define the safety of an initial administration of technetium Tc 99m LL2 monoclonal antibody in these patients. III. Demonstrate that diagnostic imaging with this agent can correctly stage patients who have been diagnosed with this disease similarly to noninvasive conventional diagnostic modalities (CDMs), primarily CT scan and bone scan. IV. Demonstrate that imaging with technetium Tc 99m LL2 monoclonal antibody is at least as sensitive for detecting disease in various body sites as any other standard diagnostic imaging method. V. Compare patient management plans based on CDMs alone, technetium Tc 99m LL2 monoclonal antibody alone, and both CDMs and technetium Tc 99m LL2 monoclonal antibody. VI. Describe the human antimouse antibody production in these patients.

OUTLINE: This is an open label, multicenter study. After all other diagnostic studies have been completed, patients receive an infusion of technetium Tc 99m LL2 monoclonal antibody by IV injection or infused over 20-30 minutes as part of their staging procedures. Planar images are acquired between 4-8 hours and 18-24 hours following antibody injection, and single photon emission computerized tomography (SPECT) imaging is performed between 4-8 hours following antibody injection. Patients may receive a repeat injection of technetium Tc 99m LL2 monoclonal antibody. Patients are followed for 3 to 6 months.

PROJECTED ACCRUAL: At least 100 patients will be accrued into this study.

Study Timeline

• Study Start: 1997-03
• Study First Submitted: 1999-11-01
• Status Verified: 2001-12
• Study First Submitted QC: 2004-03-11
• Study First Posted: 2004-03-12
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (8)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland; 🇺🇸 Baltimore, Maryland, United States

University of Texas- Houston Medical School; 🇺🇸 Houston, Texas, United States

Morton Plant Mease Health Care; 🇺🇸 Clearwater, Florida, United States

Lund University Hospital; 🇸🇪 Lund, Sweden

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Istituto Europeo Di Oncologia; 🇮🇹 Milano, Italy