Mantle-Cell Lymphoma Clinical Trial
Official title:
A Phase II Study Evaluating Combined Zevalin(Ibritumomab Tiuxetan)and Velcade(Bortezomib)in Relapsed/Refractory Mantle Cell Lymphoma
The purpose of this study is to evaluate the effects (good and bad) of the combination of
ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory
mantle cell lymphoma.
Zevalin is a monoclonal antibody that is combined with a radioactive substance and given
with another monoclonal antibody called rituximab (Rituxan). It works by attaching to cancer
cells and releasing radiation to damage those cells. Both Zevalin and Rituxan are given in
this study, along with Velcade.
This is a non-randomized, unblinded single arm Phase II trial to evaluate the combination of
yttrium90 ibritumomab tiuxetan and bortezomib in patients with relapsed/refractory mantle
cell lymphoma (MCL). Standard hematology and chemistries, imaging and bone marrow biopsies
will be done.
Research tests: 17cc of blood will be collected at screen, Day 8 OR 11 and month 3. Samples
will be collected and stored for future analysis. These analyses may include but are not
limited to measurements of proteasome inhibition. No genetic studies will be performed on
these samples. Samples will be destroyed at the end of the study.
Primary Objective Estimate the overall response rate (CR + PR) of the combination of
bortezomib and ibritumomab tiuxetan in patients with relapsed/refractory mantle cell
lymphoma.
Secondary Objectives
- Estimate the progression free and overall survival in patients with relapsed/refractory
mantle cell lymphoma who receive bortezomib and ibritumomab tiuxetan.
- Assess the toxicity of the combination of bortezomib and ibritumomab tiuxetan in
patients with relapsed/refractory MCL.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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