At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 60 enrolled

Drug / intervention

Tositumomab and Iodine I 131 Tositumomabbiological

Likely dose

Tositumomab and Iodine I 131 Tositumomab 450 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00989664

NCT00989664Phase 2Completed

Compare CT.gov

Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies

GlaxoSmithKline·interventional·Posted Oct 5, 2009·Updated Dec 13, 2016

In Brief

A Phase 2 clinical trial evaluating Tositumomab and Iodine I 131 Tositumomab for Lymphoma, Non-Hodgkin. Completed, enrolled 60 participants.

Detailed Summary

The results from Phase 1/2 (RIT-I-000) and Phase 2 (RIT-II-001) studies of Tositumomab and Iodine I 131 Tositumomab (TST/I-131 TST) demonstrated that TST/ I-131 TST produced a high response rate in patients with chemotherapy-relapsed/refractory, low-grade or transformed low-grade Non-Hodgkin's Lymphoma (NHL). On the basis of these results this study was designed to compare the efficacy of TST/ I-131 TST to the last qualifying chemotherapy regimen in patients with chemotherapy-refractory, low-grade or transformed low-grade NHL.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLymphoma, Non-Hodgkin

Countries--

Collaborators--

Timeline

Phase 2CompletedFinished

1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 1996

Primary CompletionJan 2004

Study CompletionSep 2008

First PostedOct 2009

TodayJul 2026

First PostedOct 5, 2009

Enrollment StartNov 1, 1996

Primary CompletionJan 1, 2004

Study CompletionSep 1, 2008

TodayJul 2, 2026

Enrollment to primary: 7.2 yearsPosted 16.7 years ago

Interventions

Tositumomab and Iodine I 131 Tositumomabbiological

Dosimetric Dose: 450 mg of TST infused over 70 minutes (inclusive of a 10-minute flush) immediately followed by I-131 TST (35 mg of TST, of which 1-2 mg had been labeled with 5 mCi of Iodine-131) infused over 30 minutes (inclusive of a 10-minute flush). Therapeutic Dose: 7 to 14 days after the dosimetric dose, 450 mg of TST infused over 70 minutes (inclusive of a 10-minute flush) immediately followed by I-131 TST (35 mg of TST labeled with enough Iodine-131 to administer the specified whole body radiation dose determined for the subject) infused over 30 minutes (inclusive of a 10-minute flush). The desired total body dose was 65 cGy for subjects with a baseline platelet count of 100,001-149,999/mm3 and 75 cGy for patients with a baseline platelet count ≥150,000/mm3. Obese patients received an attenuated dose by not including subject mass over 137% of their calculated lean body mass in their calculated lean body mass in the dose calculation.