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

Tracking Information
First Submitted Date ICMJE	January 30, 2009
First Posted Date ICMJE	February 2, 2009
Last Update Posted Date	March 6, 2015
Study Start Date ICMJE	February 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: January 30, 2009)	Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy; Disease-free survival at 2 years after transplant
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00833534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 30, 2009)	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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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
Official Title ICMJE	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
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Leukemia; Lymphoma
Intervention ICMJE	Biological: rituximab Given IV; Drug: lenalidomide Given orally
Study Arms	Experimental: Group I (consolidation phase) 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. Intervention: Drug: lenalidomide; Experimental: Group II (consolidation phase) 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. Interventions: Biological: rituximab Drug: lenalidomide
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Withdrawn
Actual Enrollment ICMJE; (submitted: March 4, 2015)	0
Original Estimated Enrollment ICMJE; (submitted: January 30, 2009)	20
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	United States
Administrative Information
NCT Number ICMJE	NCT00833534
Other Study ID Numbers ICMJE	2150.00; P30CA015704 ( U.S. NIH Grant/Contract ); FHCRC-2150.00; IR-6846; CDR0000633628 ( Registry Identifier: PDQ )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Leona A. Holmberg, Fred Hutchinson Cancer Research Center
Study Sponsor ICMJE	Fred Hutchinson Cancer Research Center
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: Leona A. Holmberg, MD, PhD Fred Hutchinson Cancer Research Center
PRS Account	Fred Hutchinson Cancer Research Center
Verification Date	March 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP