Lenalidomide and Vaccine Therapy in Treating Patients With Early-Stage Asymptomatic Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT01351896 | Active Not Recruiting Phase 2 Results

• 10 other identifiers: NCI-2011-02584CDR0000698438OSU 101562011C00058834N01CM00070N01CM62207P01CA095426P30CA016058P50CA140158
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the effect of lenalidomide and vaccine in treating patients with early-stage asymptomatic chronic lymphocytic leukemia or small lymphocytic lymphoma. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells.

Conditions

Ann Arbor Stage I Small Lymphocytic Lymphoma; Ann Arbor Stage II Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia; Chronic Lymphocytic Leukemia With Unmutated Immunoglobulin Heavy Chain Variable-Region Gene; Small Lymphocytic Lymphoma; Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable-Region Gene; Stage 0 Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Who Achieve an Antibody Response

  Defined as achieving at least a four-fold increase in post-vaccination serotype-specific immunoglobulin G (IgG) titers or serotype-specific IgG concentrations of \>= 0.35 ug/mL for 6 of 7 serotypes measured by a standard enzyme linked immunosorbent assay.

  Up to 1 month

Secondary Outcomes (32)

• Seroconversion Rates

  Up to 4 years

• Complete Response Rate

  At 2 years

• Time to First Treatment

  From study entry to first therapy for progressive CLL, assessed up to 4 years

• Overall Survival

  Up to 4 years

• Progression-free Survival

  Time from start of treatment to time of disease progression or death secondary to any cause, assessed up to 2 years

Study Arms (2)

Arm A (Concurrent PCV13 and lenalidomide)

EXPERIMENTAL

Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024)

Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Lenalidomide; Biological: Pneumococcal Polyvalent Vaccine

Arm B (Sequential PCV13 and lenalidomide)

EXPERIMENTAL

Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024)

Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Lenalidomide; Biological: Pneumococcal Polyvalent Vaccine

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm A (Concurrent PCV13 and lenalidomide); Arm B (Sequential PCV13 and lenalidomide)

Bone Marrow Aspiration PROCEDURE

Undergo bone marrow aspiration

Arm A (Concurrent PCV13 and lenalidomide); Arm B (Sequential PCV13 and lenalidomide)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Arm A (Concurrent PCV13 and lenalidomide); Arm B (Sequential PCV13 and lenalidomide)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm A (Concurrent PCV13 and lenalidomide); Arm B (Sequential PCV13 and lenalidomide)

Lenalidomide DRUG

Given PO

Also known as: CC 5013, CC-5013, CC5013, CDC 501, Revlimid

Arm A (Concurrent PCV13 and lenalidomide); Arm B (Sequential PCV13 and lenalidomide)

Pneumococcal Polyvalent Vaccine BIOLOGICAL

Given IM (concurrently or sequentially)

Also known as: PCV 23, Pneumococcal 23-valent Polysaccharide Vaccine, Pneumococcal Polysaccharide Vaccine, Pneumococcal Vaccine Polyvalent, Pneumovax 23, Pnu-Imune 23, PPSV, PPSV23, PPSV23 Vaccine

Arm A (Concurrent PCV13 and lenalidomide); Arm B (Sequential PCV13 and lenalidomide)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically identified chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by the World Health Organization (WHO) classification of hematopoietic neoplasms
• CLL/SLL cells must demonstrate one or more of the following high-risk genomic features:
• Deletion (Del) (17p13.1) as detected by fluorescence in-situ hybridization (FISH) in \> 20% of cells
• Del(11q22.3) as detected by FISH in \> 20% of cells
• Complex karyotype (\>= 3 cytogenetic abnormalities on stimulated karyotype)
• Unmutated immunoglobulin variable heavy chain (IgVH) (\>= 98% sequence homology compared with germline sequence)
• Patients cannot meet any of the following consensus criteria for initiating treatment:
• Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
• Progressive lymphocytosis with total white blood cell (WBC) \>= 300,000/uL
• Anemia (\< 11 g/dL) or thrombocytopenia (\< 100,000/uL) due to bone marrow involvement
• Presence of unintentional weight loss \> 10% over the preceding 6 months
• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or 3 fatigue
• Fevers \> 100.5 degrees or night sweats for \> 2 weeks without evidence of infection
• Progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of \< 6 months
• No prior therapy for CLL/SLL, including chemotherapy, radiotherapy, and/or immunotherapy will be allowed

You may not qualify if:

• Patients who have had any treatment for their CLL/SLL, including but not limited to chemotherapy, radiotherapy, or immunotherapy, prior to entering the study
• No corticosteroid use will be permitted within two weeks prior to study, except for maintenance therapy for a non-malignant disease; maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent
• Patients who meet consensus criteria for the treatment of CLL/SLL
• Patients may not be receiving any other investigational agents
• Patients with a recent history (within 6 months of study entry) of deep vein thrombosis (DVT)/pulmonary embolism (PE) are not eligible; patients with a distant history (greater than 6 months before study entry) of venous thromboembolic disease are eligible, but should receive prophylactic aspirin or low molecular weight heparin
• History of allergic reactions attributable to compounds of similar chemical or biologic composition to thalidomide, lenalidomide or any component of PCV7 or PCV13, including the diphtheria toxoid
• Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject is considered by his or her physician to have a 2 year survival expectation
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because lenalidomide is an immunomodulatory agent (IMID) with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenalidomide, breastfeeding should be discontinued if the mother is treated with lenalidomide
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy will be eligible if they otherwise meet required hematologic parameters and are not receiving an antiviral agent with known or potential interaction with lenalidomide; because the primary aim of this study is to measure the immune response to pneumococcal vaccination, only patients with CD4 cell counts \>= 200 and viral load \< 50 will be eligible
• Patients who have been treated for autoimmune hemolytic anemia or autoimmune thrombocytopenia within the last 6 months or are direct antiglobulin test/Coombs test or indirect antiglobulin test positive at the time of screening
• Patients who have developed erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs in the past are excluded
• Because of the potential for H2-blockers to modulate antibody response to pneumococcal vaccine, patients must discontinue treatment with H2-blockers (cimetidine, ranitidine, etc.) prior to beginning protocol therapy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Specimen Handling; Biopsy; Lenalidomide; Pneumococcal Vaccines; 23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; 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; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Kerry Rogers
• Organization: The Ohio State University Comprehensive Cancer Center

Kerry.Rogers@osumc.edu

614-293-3873

Study Officials

• Kerry Rogers

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 11, 2011
• Study Start: November 2, 2011
• Primary Completion: July 8, 2024
• Study Completion: May 6, 2026
• Last Updated: November 20, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-11

Locations

US (1)