Lenalidomide With or Without Rituximab After Standard Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00765245
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Lenalidomide — DRUG
    Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
  • Lenalidomide — DRUG
    Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles
  • Rituximab — DRUG
    Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization.

Study Details

RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether lenalidomide is more effective with or without rituximab in treating diffuse large B-cell non-Hodgkin lymphoma. PURPOSE: This randomized phase II trial is studying lenalidomide to see how well it works when given with or without rituximab after standard chemotherapy in treating patients with diffuse large B-cell non-Hodgkin lymphoma.

Key Dates

Start date
Oct 31, 2008
Status verified
Mar 2016
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I: Lenalidomide
  • Experimental: Arm II: Lenalidomide and Rituximab IV
    Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Disease-free Survival at 1 Year [ Time Frame: From on-treatment date to disease recurrence, up to 1 year ]

Locations (4)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6838-
Vanderbilt-Ingram Cancer Center - Cool SpringsNashvilleTennessee37064-
Vanderbilt-Ingram Cancer Center at FranklinNashvilleTennessee37064-

Find similar trials in Chapel Hill, NC

By research site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NCVanderbilt-Ingram Cancer Center· Nashville, TNVanderbilt-Ingram Cancer Center - Cool Springs· Nashville, TNVanderbilt-Ingram Cancer Center at Franklin· Nashville, TN

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