A Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Non-Hodgkin's Lymphoma
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.