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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Rituximab — BIOLOGICAL
  Given IV
• Yttrium Y-90 Ibritumomab Tiuxetan — RADIATION
  Given IV

Study Details

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.

Key Dates

Start date

Feb 11, 2015

Status verified

Nov 2023

Primary completion

Feb 28, 2021

Completion

Nov 9, 2023

Study Design

Enrollment

20 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (rituximab)
  Patients receive rituximab IV on days 1, 8, 15, and 22.
• Experimental: Arm B (rituximab, yttrium Y-90 ibritumomab tiuxetan)
  Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.

Primary Outcome Measure

Complete Response (CR) Rate at the 6-month Disease Assessment [ Time Frame: 6 months ]

Locations (1)

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