Lenalidomide With or Without Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Undergone Autologous or Syngeneic Stem Cell Transplant
- Registration Number
- NCT00833534
- Lead Sponsor
- Fred Hutchinson Cancer Center
- Brief Summary
RATIONALE: Biological therapies, such as 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. It is not yet known whether lenalidomide is more effective with or without rituximab in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.
PURPOSE: This phase II trial is studying how well lenalidomide works when given with or without rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplant.
- Detailed Description
OBJECTIVES:
Primary
* To evaluate the efficacy of consolidation therapy comprising lenalidomide with or without rituximab followed by maintenance therapy comprising lenalidomide in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplantation.
OUTLINE:
* Consolidation phase: Patients are assigned to 1 of 2 treatment groups.
* Group I: Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
* Group II: Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity.
* Maintenance phase: Beginning 2 months after completion of consolidation therapy, all patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 18 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 28 days and then annually thereafter.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group I (consolidation phase) lenalidomide Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Group II (consolidation phase) rituximab Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity. Group II (consolidation phase) lenalidomide Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy Disease-free survival at 2 years after transplant
- Secondary Outcome Measures
Name Time Method Toxicity during consolidation and maintenance therapy as assessed by NCI CTCAE v3.0 Ability to complete planned therapy Complete hematological remission, including bone marrow IgH remission status as assessed by PCR after consolidation and maintenance therapy Time to disease progression Relapse rates