Clinical trial NCT00784927
Conditions: Lymphoma
Keywords: stage I grade 1 follicular lymphoma contiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma stage III grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma stage I grade 2 follicular lymphoma contiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 2 follicular lymphoma stage I small lymphocytic lymphoma contiguous stage II small lymphocytic lymphoma noncontiguous stage II small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma Waldenstrom macroglobulinemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma stage I marginal zone lymphoma contiguous stage II marginal zone lymphoma noncontiguous stage II marginal zone lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma
Sponsor: Mayo Clinic
Start date: 2008-11-01; Completion date: 2016-02-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. 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 and dexamethasone, 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, cyclophosphamide, and dexamethasone may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab, cyclophosphamide, and dexamethasone works in treating patients with previously untreated low-grade non-Hodgkin lymphoma.

Detailed description:
OBJECTIVES:

Primary

* To assess tumor response to lenalidomide, rituximab, cyclophosphamide, and dexamethasone in patients with symptomatic previously untreated low-grade non-Hodgkin lymphoma.

Secondary

* To describe the adverse event profile of this regimen.
* To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure associated with this regimen.
* To estimate tumor response to lenalidomide, rituximab, cyclophosphamide and dexamethasone in the subgroup of patients with lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia).

OUTLINE: This is a multicenter study.

Patients receive oral lenalidomide once daily on days 1-21, rituximab IV on day 1, oral cyclophosphamide once daily on days 1, 8, and 15, and oral dexamethasone once daily on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 5 years.

Arms: arm 1: Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:

375 mg/m\^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m\^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22.
Interventions: intervention 1: rituximab intervention 2: cyclophosphamide intervention 3: dexamethasone intervention 4: lenalidomide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: