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
- Conditions
- Lymphoma
- Registration Number
- NCT00670358
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* To determine the maximum tolerated dose of lenalidomide when given in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in patients with newly diagnosed stage II-IV diffuse large cell or grade 3 follicular B-cell lymphoma. (Phase I)
* To assess the efficacy of this regimen, in terms of event-free survival and response rate, in these patients. (Phase II)
* To assess the safety of this regimen in these patients. (Phase II)
Secondary
* To assess the host immune function at baseline and after treatment and correlate these parameters with tumor response and event-free survival.
OUTLINE: This is a multicenter, phase I dose-escalation study of lenalidomide followed by a phase II study.
* Phase I: Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisone on days 1-5, and oral lenalidomide on days 1-10. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Phase II: Patients receive lenalidomide at the maximum tolerated dose determined in phase I and rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and pegfilgrastim as in phase I.
Blood is collected at baseline, before course 3, and after completion of study treatment for translational research studies. Research studies include immune function and cytokine analysis, T- and B- quantitative lymphocyte analysis, and single nucleotide polymorphism analysis.
After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Toxicity as Assessed by NCI CTCAE v3.0 (Phase I) 5 years Event-free > Survival at 12 Months (Phase 2, DLBCL/Mixed Dose Level 3) 1 year Other Phase II Cohorts were not evaluable for event-free survival analysis.
Progression-free > Survival at 24 Months (Phase 2, Transformed/Composite) 2 years Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Other Phase II Cohorts were not evaluable for progression-free survival analysis.
- Secondary Outcome Measures
Name Time Method Event-free Survival 5 years Overall Survival 5 years Progression-free Survival 5 years Duration of Response 5 years Immune Function Before and After Treatment as Assessed by T-, B-, and NK-cell Quantification 5 years Correlation of Immune Function With Clinical Outcomes 5 years Overall Response Rate When all patients either have a CR or have completed observation. Overall Complete Response Rate When all patients either have a CR or have completed observation.
Trial Locations
- Locations (3)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States