Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT00670358
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • pegfilgrastim — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • cyclophosphamide — DRUG
  • doxorubicin hydrochloride — DRUG
  • lenalidomide — DRUG
  • prednisone — DRUG
  • vincristine sulfate — DRUG
  • polymorphism analysis — GENETIC
  • laboratory biomarker analysis — OTHER

Study Details

RATIONALE: Lenalidomide may 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large cell or follicular B-cell lymphoma.

Key Dates

Start date
Aug 25, 2008
Status verified
Dec 2024
Primary completion
May 7, 2021
Completion
Oct 4, 2024

Study Design

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

Primary Outcome Measure

Toxicity as Assessed by NCI CTCAE v3.0 (Phase I) [ Time Frame: 5 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-5499-
Mayo Clinic in FloridaJacksonvilleFlorida32224-
Mayo ClinicRochesterMinnesota55905-

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