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
18 Years
N/A
Both
Leukemia, Lymphoma
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy
Safety Issue:
No
Principal Investigator
Leona A. Holmberg, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Food and Drug Administration
Study ID:
2150.00
NCT ID:
NCT00833534
Start Date:
February 2009
Completion Date:
Related Keywords:
- Leukemia
- Lymphoma
- 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
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoma
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