Cancer Care

 

 
A Multicenter, Open Label, Phase II Study of Bendamustine and Rituximab followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma (Fol-BRITe study)
Principal Investigator (?)
Study Number
D1015
Summary
The purpose of the study is to learn about the safety and effectiveness of treating
follicular lymphoma with bendamustine and rituximab followed by radioimmunotherapy (RIT)
using 90-yttrium (Y) ibritumomab tiuxetan.

The researchers will also test blood and bone marrow for the BCL2 gene-Jh that is a commonly
found in people with follicular lymphoma (FL) and look at how the BCL2 gene-Jh responds to
the study treatment.

Bendamustine is approved by the United States Food and Drug Administration (FDA) for the
treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin''s lymphoma (NHL)
that has progressed during or within six months of treatment with rituximab or a
rituximab-containing treatment regimen. Bendamustine is not approved by the FDA to treat
follicular lymphoma.

Rituximab is approved by the FDA for the treatment of relapsed or refractory, low-grade or
follicular, CD20-positive B-cell non-Hodgkin''s lymphoma.

90-yttrium (Y) ibritumomab tiuxetan is approved by the FDA for the treatment of relapsed or
refractory, low-grade or follicular B-cell NHL, including rituximab refractory follicular
NHL. It is also approved for the treatment of follicular NHL that is previously untreated
with radioimmunotherapy and that achieved a partial or complete response to first-line
chemotherapy.

Study participants will will receive bendamustine and rituximab for up to 16 weeks. If
participants'' cancer responds well to the treatment with bendamustine and rituximab, they
will receive up to 12 weeks of radioimmunotherapy (RIT). After the RIT is complete,
participants will be asked to return to the clinic every 3 months for a maximum of 10 years
for follow-up visits.
Phase (?)
Phase II
Sponsor (?)
Available at the following location(s)

Lebanon
Manchester

View more details from ClinicalTrials.gov.

Contact Information

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Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.