NCT01351896

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

Phase II Study of Lenalidomide to Repair Immune Synapse Response and Humoral Immunity in Early-Stage, Asymptomatic Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) With High-Risk Genomic Features

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the proportion of early-stage, high-risk chronic lymphocytic leukemia (CLL) patients achieving a response (\>= 4-fold increase from baseline and/or antibody concentrations \>= 0.35 ug/mL in 6 of 7 type-specific anti-pneumococcal antibody levels) after 2 doses of pneumococcal 13-valent conjugated vaccine (Prevnar 13, PCV13 \[pneumococcal polyvalent vaccine\]) administered concurrent with versus sequential to low-dose lenalidomide. SECONDARY OBJECTIVES: I. To determine the complete response (CR) rate after 2 years of lenalidomide therapy. II. To determine the time to first treatment (TFT), defined as the time from diagnosis to first non-lenalidomide therapy for progressive CLL as described by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria. III. To determine the incidence of infection and invasive pneumococcal infections following treatment with the PCV13 vaccine and either concurrent or sequential lenalidomide. IV. To determine the frequency of humoral and cellular immune response to CLL tumor antigens following treatment with the PCV13 vaccine and either concurrent or sequential lenalidomide. V. To determine the safety and toxicity associated with long-term lenalidomide exposure. VI. To perform correlative pharmacodynamic and pharmacokinetic studies and correlate these with vaccine/tumor immunologic and disease response. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A (concurrent PCV13 and lenalidomide): Patients receive low-dose lenalidomide orally (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 13-valent protein-conjugated pneumococcal vaccine (PCV13) intramuscularly (IM) on day 1 of courses 3 and 5. ARM B (sequential PCV13 and lenalidomide): 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 cycle 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 computed tomography (CT) during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) After completion of study treatment, patients are followed up for 30 days, every 3 months for 1 year, and then every 6 months thereafter.

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

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow biopsy
PROCEDURE	Computed Tomography	Undergo CT
DRUG	Lenalidomide	Given PO
BIOLOGICAL	Pneumococcal Polyvalent Vaccine	Given IM (concurrently or sequentially)

Timeline

• Start date: 2011-11-02
• Primary completion: 2024-07-08
• Completion: 2026-05-06
• First posted: 2011-05-11
• Last updated: 2025-11-20
• Results posted: 2025-08-22

Locations

1 site across 1 country: United States