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

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00833534

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma	Biological: rituximab Drug: lenalidomide	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: lenalidomide Given orally
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.	Biological: rituximab Given IV Drug: lenalidomide Given orally

Arm

Intervention/Treatment

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.

Drug: lenalidomide

Given orally

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.

Biological: rituximab

Given IV

Drug: lenalidomide

Given orally

Outcome Measures

Primary Outcome Measures

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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