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Radioimmunotherapy

Rituximab vs. Radioimmunotherapy for Non-Hodgkin's Lymphoma

Phase 3

Waitlist Available

Research Sponsored by Corixa Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of follicular lymphoma, Grade I, II, or III (WHO/REAL Classification)

Recurrent lymphoma after one or two qualifying therapy regimen(s)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will enroll 506 patients 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. Patients 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

Who is the study for?

This trial is for adults with a specific type of Non-Hodgkin's Lymphoma who have had the disease return after one or two treatments. They must be HAMA negative, have good kidney and liver function, measurable disease by CT scan, and acceptable blood cell counts. Not eligible if they've had recent therapy, CNS lymphoma involvement, significant heart issues, certain infections or other cancers.Check my eligibility

What is being tested?

The study compares Rituximab infusion treatment against Iodine I 131 Tositumomab therapy in patients with Non-Hodgkin's Lymphoma. Patients are randomly assigned to receive either weekly Rituximab infusions for four weeks or a two-phase Tositumomab treatment involving dosimetric and therapeutic doses.See study design

What are the potential side effects?

Rituximab can cause infusion reactions like fever and chills; low blood cell counts increasing infection risk; skin rashes; fatigue; and organ inflammation. Iodine I 131 Tositumomab may lead to similar side effects plus radiation-related issues such as dry mouth/throat due to thyroid damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma is confirmed as Grade I, II, or III follicular type.

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My lymphoma has returned after 1 or 2 treatments.

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I have a tumor that is at least 2cm large as shown by a CT scan.

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I am 18 years old or older.

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I can care for myself but cannot do normal activities or work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Corixa CorporationLead Sponsor

9 Previous Clinical Trials

84 Total Patients Enrolled

Media Library

Iodine I 131 Tositumomab (Radioimmunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00078598 — Phase 3

Non-Hodgkin's Lymphoma Research Study Groups:

Non-Hodgkin's Lymphoma Clinical Trial 2023: Iodine I 131 Tositumomab Highlights & Side Effects. Trial Name: NCT00078598 — Phase 3

Iodine I 131 Tositumomab (Radioimmunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00078598 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different parts of the country is this trial being conducted?

"This study has locations in Atlanta, GA, Dayton, OH and Walla Walla, WV with 5 additional sites."

Answered by AI

Does this experiment still need more participants?

"The listing for this study on clinicaltrials.gov suggests that it is not currently enrolling patients. This trial was first posted on April 1st, 2004 and last updated November 8th, 2005. There are 1818 other trials actively recruiting patients right now."

Answered by AI

Can elderly patients participate in this research?

"Eligibility requirements for this clinical study include being 18 years old or older."

Answered by AI

Has this medication been cleared by the FDA?

"This treatment received a safety score of 3 from our team at Power. This is because the treatment is currently in Phase 3 clinical trials, which suggests that there is some data supporting efficacy as well as multiple rounds of data supporting safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2004. "A Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Non-Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00078598.

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