Phase I/II Study of Lenalidomide (Revlimid), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R2CHOP) Chemoimmunotherapy in Patients With Newly Diagnosed Diffuse Large Cell and Follicular Grade IIIA/B B Cell Lymphoma
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 138
- Locations
- 6
- Primary Endpoint
- Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)
Time Frame: 5 years
Event-free > Survival at 12 Months (Phase 2, DLBCL/Mixed Dose Level 3)
Time Frame: 1 year
Other Phase II Cohorts were not evaluable for event-free survival analysis.
Progression-free > Survival at 24 Months (Phase 2, Transformed/Composite)
Time Frame: 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 Outcomes
- 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.)