Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Trial of Bortezomib (NSC #681239) + Lenalidomide (Revlimid™, CC-5013) (NSC #703813) for Relapsed/Refractory Mantle Cell Lymphoma
This phase II trial studies how well bortezomib and lenalidomide work in treating patients with mantle cell lymphoma that has come back after a period of improvement (refractory) or is not responding to treatment (refractory). Bortezomib may also stop the growth of cancer cells by blocking some proteins needed for cell growth. Lenalidomide may stimulate the immune system to kill cancer cells and may also block the growth of new blood vessels necessary for cell growth. Giving bortezomib with lenalidomide may be an effective treatment for relapsed or refractory mantle cell lymphoma.
PRIMARY OBJECTIVES:
I. To determine the overall response (complete response [CR] and partial response [PR]) rate
and the complete response (CR) rate to bortezomib + lenalidomide therapy in patients with
relapsed or refractory mantle cell lymphoma.
SECONDARY OBJECTIVES:
I. To determine the time to progression after therapy with bortezomib + lenalidomide in
patients with relapsed or refractory mantle cell lymphoma.
II. To determine the disease-free survival and overall survival after therapy with bortezomib
+ lenalidomide in patients with relapsed or refractory mantle cell lymphoma.
OUTLINE:
Patients receive induction therapy comprising bortezomib intravenously (IV) over 3-5 seconds
on days 1, 4, 8, and 11 and lenalidomide orally (PO) once daily (QD) on days 1-14. Treatment
repeats every 21 days for up to 8 courses in the absence of disease progression or
unacceptable toxicity. Patients achieving a complete or partial response as best response
after completion of induction therapy receive maintenance therapy comprising bortezomib IV on
days 1 and 8 and lenalidomide PO QD on days 1-14. Treatment repeats every 21 days for up to 6
years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 2 years, and then annually for 2 years.
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