Rituximab, Lenalidomide, and Nivolumab in Treating Participants With Relapsed or Refractory Non-Germinal Center Type Diffuse Large B Cell Lymphoma or Primary Central Nervous System Lymphoma

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT03558750
Phase
PHASE1
Status
Terminated

Conditions

  • Recurrent Central Nervous System Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Refractory Central Nervous System Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Given by IV
  • Rituximab — BIOLOGICAL
    Given by IV
  • Lenalidomide — DRUG
    Given by mouth

Study Details

This phase I/II trial studies the side effects and best dose of lenalidomide when given in combination with rituximab and nivolumab and how well they work in treating participants with non-germinal center type diffuse large B cell lymphoma or primary central nervous system lymphoma that has come back or isn't responding to treatment. Monoclonal antibodies, such as rituximab and nivolumab, may interfere with ability of cancer 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 rituximab, lenalidomide, and nivolumab may work better in treating participants with diffuse large B cell lymphoma.

Key Dates

Start date
Jun 14, 2018
Status verified
Apr 2019
Primary completion
Apr 16, 2019
Completion
Apr 16, 2019

Study Design

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

Arms

  • Experimental: Treatment (nivolumab, rituximab, lenalidomide)
    Nivolumab give by IV over 60 minutes on days 1 and 15, rituximab IV on day 1, and lenalidomide by mouth once per day on days 1-21. Repeats every 28 days for up to of 8 courses in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease at the end of 8 cycles will be offered lenalidomide and nivolumab maintenance for up to 12 courses.

Primary Outcome Measure

Dose limiting toxicity (DLT) (Phase I) [ Time Frame: At the end of cycle 2 (each cycle is 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

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By research site
Vanderbilt-Ingram Cancer Center· Nashville, TN

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