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

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03232307
Phase
PHASE2
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
ALL
Age
66 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Given PO
  • Ibrutinib — DRUG
    Given PO
  • Lenalidomide — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jul 1, 2019
Status verified
Aug 2019
Primary completion
Jul 1, 2021
Completion
Jul 1, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ibrutinib, rituximab, lenalidomide, dexamethasone)
    Participants receive ibrutinib PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Participants also receive rituximab 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.

Primary Outcome Measure

Overall response rate (ORR) per International Workshop Standardization Response Criteria for non-Hodgkin's lymphoma [ Time Frame: At 4 months (each cycle is 28 days) ]

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