CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomabbiological
Likely dose
Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab 450 milligramsfrom 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/NCT01224821
NCT01224821Phase 2Completed
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Multicenter, Phase II Dosimetry/Validation Study of 131Iodine-Anti B1 (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 20, 2010·Updated Dec 12, 2016

In Brief

A Phase 2 clinical trial evaluating Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab for Lymphoma, Non-Hodgkin. Completed, enrolled 47 participants.

Detailed Summary

Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The primary objective of this study is to demonstrate that each site could accurately conduct the whole body dosimetry required for the safe and effective dosing of Iodine-131 Anti-B1 Antibody. Additional objectives of this study are to evaluate the efficacy, dosimetry, and safety of Iodine-131 Anti-B1 Antibody.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Non-Hodgkin
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
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First PostedOct 20, 2010
Enrollment StartDec 1, 1995
Primary CompletionNov 1, 1997
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.7 years ago

Interventions

Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomabbiological

Patients receive a dosimetric dose consisting of 450 milligrams (mg) of unlabeled tositumomab (TST, Anti-B1 Antibody) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after administration and then daily for the next 7 days were used to determine the radioactive clearance and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose. The therapeutic dose was administered 7-14 days after the dosimetric dose and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST.