NCT03232307

Ibrutinib Plus Rituximab and Lenalidomide in Treating Elderly Participants With Newly Diagnosed Mantle Cell Lymphoma

A Phase II Study of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed MCL

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 66 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• CCND1 Positive
• CD20-Positive Neoplastic Cells Present
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given PO
DRUG	Ibrutinib	Given PO
DRUG	Lenalidomide	Given PO
BIOLOGICAL	Rituximab	Given IV

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2017-07-27
• Last updated: 2019-08-22

Regulatory

• FDA-regulated drug study