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Rituximab With or Without Yttrium Y-90 Ibritumomab Tiuxetan in Treating Patients With Untreated Follicular Lymphoma

NCT02320292 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-09

Study results available
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Summary

This phase III trial studies rituximab and yttrium Y-90 ibritumomab tiuxetan to see how well they work compared to rituximab alone in treating patients with untreated follicular lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radioactive substances linked to monoclonal antibodies can bind to cancer cells and give off radiation which may help kill cancer cells. It is not yet known whether rituximab works better with or without yttrium Y-90 ibritumomab tiuxetan in treating follicular lymphoma.

Conditions

  • Ann Arbor Stage I Grade 1 Follicular Lymphoma
  • Ann Arbor Stage I Grade 2 Follicular Lymphoma
  • Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma
  • Ann Arbor Stage II Grade 1 Non-Contiguous Follicular Lymphoma
  • Ann Arbor Stage II Grade 2 Contiguous Follicular Lymphoma
  • Ann Arbor Stage II Grade 2 Non-Contiguous Follicular Lymphoma
  • Ann Arbor Stage III Grade 1 Follicular Lymphoma
  • Ann Arbor Stage III Grade 2 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 1 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 2 Follicular Lymphoma

Interventions

OTHER

Quality-of-Life Assessment

Ancillary studies

BIOLOGICAL

Rituximab

Given IV

RADIATION

Yttrium Y-90 Ibritumomab Tiuxetan

Given IV

Sponsors & Collaborators

Principal Investigators

  • Thomas E. Witzig, M.D. · Mayo Clinic in Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-11
Primary Completion
2021-02-28
Completion
2023-11-09

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02320292 on ClinicalTrials.gov