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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Consolidation Therapy With Lenalidomide (Revlimid®) With or Without Rituximab Followed by Maintenance Therapy With Revlimid® After Autologous/Syngeneic Transplant for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Conditions
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Leukemia, Lymphoma

Intervention / Treatment
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* Biological: rituximab
* Drug: lenalidomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Any stage disease Prior histological documentation of CD20+ CLL or SLL Has undergone autologous or syngeneic stem cell transplantation comprising high-dose therapy with peripheral blood stem cell rescue within the past 30-120 days No progressive disease after transplantation Has had stable disease or some degree of response to transplantation No history of CNS involvement PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% Platelet count ≥ 50,000/mm³* (transfusion independent) ANC ≥ 1,500/mm³* Total bilirubin ≤ 2 mg/mL (unless due to Gilbert's disease) SGOT/SGPT ≤ 2.5 times upper limit of normal Serum creatinine ≤ 2 mg/mL Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 effective methods of contraception for at least 28 days before, during, and for at least 28 days after completion of study therapy Patients and their physician must be registered in the RevAssist® program and be willing and able to comply with the requirements of RevAssist® LVEF ≥ 45% immediately prior to transplant No uncontrolled congestive heart disease No history of myocardial infarction or coronary artery disease No peripheral neuropathy ≥ grade 3 No allergy to lenalidomide, thalidomide, allopurinol, or rituximab No known hepatitis B, hepatitis C, or HIV seropositivity No other malignancies within the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast No concurrent serious uncontrolled medical or psychiatric illness, including serious infection NOTE: *For 5 calendar days after transplant PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior CD34-selected stem cell product No chemotherapy or biologic therapy for CLL after transplant Prior rituximab administered before stem cell collection allowed Prior lenalidomide administered before transplant allowed provided patient responded to lenalidomide No concurrent sargramostim (GM-CSF) No other concurrent anticancer therapies, including radiotherapy or thalidomide No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (consolidation phase)<br>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. | Drug: lenalidomide<br>* Given orally<br>|
| Experimental: Group II (consolidation phase)<br>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. | Biological: rituximab<br>* Given IV<br>Drug: lenalidomide<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II small lymphocytic lymphoma