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Lenalidomide

Heptavalent Pneumococcal Conjugate Vaccine

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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 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.

Laboratory Biomarker Analysis

Pharmacological Study

Pneumococcal Polyvalent Vaccine

Kerry Rogers

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.

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.

After completion of study treatment, patients are followed up for 30 days, every 3 months for 1 year, and then every 6 months thereafter.

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

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.

Summarized using descriptive statistics by treatment arm.

Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations.

95% confidence intervals will be estimated.

Defined by International Workshop on chronic lymphocytic leukemia (CLL) (IWCLL) 2008 criteria. Summarized and explored between treatment arms using Kaplan-Meier methods.

Summarized and explored between treatment arms using Kaplan-Meier methods.

Summarized by and across treatment arms, along with the type, severity, and perceived attribution to study according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5. The rates of severe (grade 3+) toxicity (at least possibly related to treatment) and non-hematologic toxicity will be summarized; assuming the incidence of severe toxicity is binomially distributed, 95% confidence intervals will be calculated. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine the toxicity patterns.

PK will be graphically evaluated within and across arms to assess potential patterns and relationships.

Pharmacodynamic markers will be graphically evaluated within and across arms to assess potential patterns and relationships.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Lenalidomide and Vaccine Therapy in Treating Patients With Early-Stage Asymptomatic Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma	NCT01351896	Ann Arbor Stage... Ann Arbor Stage... Chronic Lymphoc... Chronic Lymphoc... Small Lymphocyt... Small Lymphocyt... Stage 0 Chronic... Stage I Chronic... Stage II Chroni...	Laboratory Biom... Lenalidomide Pharmacological... Pneumococcal Po...	18 Years - 79 Years	National Cancer Institute (NCI)
Lenalidomide and Vaccine Therapy in Treating Patients With Early-Stage Asymptomatic Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma	NCT01351896	Ann Arbor Stage... Ann Arbor Stage... Chronic Lymphoc... Chronic Lymphoc... Small Lymphocyt... Small Lymphocyt... Stage 0 Chronic... Stage I Chronic... Stage II Chroni...	Laboratory Biom... Lenalidomide Pharmacological... Pneumococcal Po...	18 Years - 79 Years	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for ann arbor stage ii small lymphocytic lymphoma