Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed MCL
This phase II trial studies how well ibrutinib plus rituximab and lenalidomide work in treating elderly participants with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib plus rituximab and lenalidomide may work better in treating elderly participants with newly diagnosed mantle cell lymphoma.
PRIMARY OBJECTIVES:
I. To evaluate the overall response rate (ORR) at 4 months of ibrutinib plus rituximab and
lenalidomide in elderly patients with newly-diagnosed, untreated mantle cell lymphoma (MCL).
SECONDARY OBJECTIVES:
I. To evaluate the toxicity profile of the combination of ibrutinib plus rituximab and
lenalidomide in newly diagnosed, untreated MCL.
II. To estimate the overall response rate (ORR); (partial response [PR] or better), the
response duration (DOR), progression-free survival (PFS), time to progression (TTP) and
overall survival (OS). Clinical benefit response [(CBR) = marginal response (MR) + ORR] will
also be evaluated.
EXPLORATORY OBJECTIVES:
I. Correlative studies will be aimed at confirming the mechanism of action of the combination
and to identify predictors of response or resistance to therapy.
OUTLINE:
Participants receive ibrutinib orally (PO) on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity. Participants also receive rituximab
intravenously (IV) on days 1, 8, 15 and 22 in course 1 and 2, on day 1 of course 3-8, and
then on day 1 of every other 28-day course, lenalidomide PO on days 1-21, and dexamethasone
PO weekly. Treatment with rituximab repeats every 28 days for 2 years, with lenalidomide for
1 year, and with dexamethasone for up to 2 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 days, every 3 months
for 1 year, and every 6 months thereafter.
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