A Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Non-Hodgkin's Lymphoma

Phase 3

• Conditions: Non-Hodgkin's Lymphoma

• Registration Number: NCT00078598
• Lead Sponsor: Corixa Corporation

Brief Summary

A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States and Europe.

Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will receive 375 mg/m2 of rituximab (US, Canada - Rituxan®; EU - Mabthera®), given as an IV infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the "dosimetric dose," patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi (0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0, Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data from these three imaging timepoints, the patient's weight, and platelet count, a patient-specific administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq) will be calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In the second phase, termed the "therapeutic dose," patients in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient-specific administered activity of Iodine 131-conjugated Tositumomab (35 mg).

Patients on study will be followed for response and safety at Week 7, Week 13, and every 3 months for the first and second years, every 6 months for the third year, and then annually for the fourth and fifth years. Patients will be followed for safety only annually for years 6-10.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-03-01
• Study First Submitted QC: 2004-03-02
• Study First Posted: 2004-03-03
• Study Start: 2004-04
• Status Verified: 2004-10
• Last Update Submitted: 2005-11-08
• Last Update Posted: 2005-11-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 506

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (5)

Medical Oncology/Hematology Associates; 🇺🇸 Dayton, Ohio, United States

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States

St Mary Medical Center/Regional Cancer Center; 🇺🇸 Walla Walla, Washington, United States

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

West Virginia University/Mary Babb Randolph Cancer Center; 🇺🇸 Morgantown, West Virginia, United States