Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• rituximab — BIOLOGICAL
  Given IV
• lenalidomide — DRUG
  Given orally

Study Details

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. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Giving rituximab together with lenalidomide may kill more cancer cells. This randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.

Key Dates

Start date

Mar 31, 2006

Status verified

Feb 2017

Primary completion

Jun 30, 2012

Completion

Aug 31, 2015

Study Design

Enrollment

97 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I - rituximab
  Patients receive rituximab IV on days 1, 8, 15, and 22.
• Experimental: Arm II - lenalidomide
  Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm III - lenalidomide and rituximab
  Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, 22 and 29.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Duration of treatment (12 cycles) ]

Locations (79)

Find similar trials in La Jolla, CA

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