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

NCT00833534 | Withdrawn Phase 2

• 5 other identifiers: 2150.00P30CA015704FHCRC-2150.00IR-6846CDR0000633628
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukemia; Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy

• Disease-free survival at 2 years after transplant

Secondary Outcomes (5)

• 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

Study Arms (2)

Group I (consolidation phase)

EXPERIMENTAL

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

Group II (consolidation phase)

EXPERIMENTAL

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; Drug: lenalidomide

Interventions

rituximab BIOLOGICAL

Given IV

Group II (consolidation phase)

lenalidomide DRUG

Given orally

Group I (consolidation phase); Group II (consolidation phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Leukemia; Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Leona A. Holmberg, MD, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: February 1, 2009
• Last Updated: March 6, 2015

Record last verified: 2015-03