Lenalidomide in Combination With Rituximab in Treating Participants With Stage III/IV Indolent Non-Hodgkin Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00695786
Phase
PHASE2
Status
Completed

Conditions

  • Ann Arbor Stage III Grade 1 Follicular Lymphoma
  • Ann Arbor Stage III Grade 2 Follicular Lymphoma
  • Ann Arbor Stage III Indolent Adult Non-Hodgkin Lymphoma
  • Ann Arbor Stage III Marginal Zone Lymphoma
  • Ann Arbor Stage III Small Lymphocytic Lymphoma
  • Ann Arbor Stage IV Grade 1 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 2 Follicular Lymphoma
  • Ann Arbor Stage IV Indolent Adult Non-Hodgkin Lymphoma
  • Ann Arbor Stage IV Marginal Zone Lymphoma
  • Ann Arbor Stage IV Small Lymphocytic Lymphoma

Eligibility Criteria

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

Interventions

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

Study Details

This phase II trial studies how well lenalidomide works in combination with rituximab in treating participants with stage III-IV non-Hodgkin lymphoma that is growing slowly. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth, which may prevent the growth of cancer cells. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide and rituximab may work better in participants with indolent non-Hodgkin lymphoma.

Key Dates

Start date
Jun 10, 2008
Status verified
Sep 2021
Primary completion
Jul 11, 2020
Completion
Jul 11, 2020

Study Design

Enrollment
156 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Schedule A (lenalidomide, rituximab)
    Participants receive lenalidomide PO on days 1-21 and rituximab IV over 4-8 hours on day 1 of courses 1-12. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
  • Experimental: Schedule B (lenalidomide, rituximab)
    Participants receive lenalidomide PO on days 2-22 and rituximab IV over 4-8 hours on days 1, 8, 15, and 22 of course 1 and on day 1 of all subsequent courses. Courses repeat every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Best Overall Disease Response [ Time Frame: At the end of 3 courses (84 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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