Lenalidomide in Improving Immune Response to Vaccine Therapy in Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Monoclonal B Cell Lymphocytosis

NCT02309515 | Terminated Phase 2 Results DMC

• 4 other identifiers: MC138ENCI-2014-02373RV-CL-CLL-PI-003938P30CA015083
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

This randomized phase II trial studies how well lenalidomide improves immune response to pneumococcal 13-valent conjugate vaccine in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or monoclonal B cell lymphocytosis. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Lenalidomide may also improve the effectiveness of pneumococcal 13-valent conjugate vaccine that is used to prevent infection.

Conditions

Monoclonal B-Cell Lymphocytosis; Stage 0 Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage I Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Successful Response

  Rate of response to pneumococcal 13-valent conjugate vaccine defined as a four-fold rise from baseline to 28 days after immunization (day 43) for \>= 2 of the 3 serotypes studied by OPA of antibodies from sera. The proportion of successes will be estimated in each arm by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated in each arm based on the normal approximation.

  Day 43

Secondary Outcomes (3)

• Disease Status by Physical Exam and Complete Blood Counts

  At 6 weeks

• Incidence of Adverse Events Using NCI Common Terminology Criteria for Adverse Events Version 4.0

  Up to day 50

• Time to Treatment for Progressive CLL

  Time from the date of registration to the date of initiation of treatment for progressive CLL assessed up to 2 years

Study Arms (2)

Arm I (lenalidomide, pneumococcal 13-valent conjugate vaccine)

EXPERIMENTAL

Patients receive lenalidomide PO QD on days 1-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.

Other: Laboratory Biomarker Analysis; Drug: Lenalidomide; Biological: Pneumococcal 13-valent Conjugate Vaccine

Arm II (pneumococcal 13-valent conjugate vaccine)

ACTIVE COMPARATOR

Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.

Other: Laboratory Biomarker Analysis; Biological: Pneumococcal 13-valent Conjugate Vaccine

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (lenalidomide, pneumococcal 13-valent conjugate vaccine); Arm II (pneumococcal 13-valent conjugate vaccine)

Lenalidomide DRUG

Given PO

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

Arm I (lenalidomide, pneumococcal 13-valent conjugate vaccine)

Pneumococcal 13-valent Conjugate Vaccine BIOLOGICAL

Given IM

Also known as: PCV 13, PCV13 Vaccine, Prevnar 13

Arm I (lenalidomide, pneumococcal 13-valent conjugate vaccine); Arm II (pneumococcal 13-valent conjugate vaccine)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of:
• CLL according to the National Cancer Institute (NCI) criteria
• Small lymphocytic lymphoma (SLL) according to the World Health Organization (WHO) criteria
• MBL according to the consensus criteria
• This includes previous documentation of:
• Biopsy-proven small lymphocytic lymphoma or
• Diagnosis of CLL or MBL as evidenced by all of the following:
• Clonal B-cell population in the peripheral blood with immunophenotyping consistent with CLL defined as:
• The population of lymphocytes share both B-cell antigens (cluster of differentiation \[CD\]19, CD20 \[typically dim expression\], or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc)
• Clonality as evidenced by k (kappa) or lambda light chain expression (typically dim immunoglobulin expression) or other genetic method (e.g. immunoglobulin heavy chain variable \[IGHV\] analysis) NOTE: splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
• Patients with a peripheral blood B-cell lymphocyte count of \< 5 x 10\^9/L and no evidence of lymphadenopathy or organomegaly will be classified as MBL; patients with a peripheral blood B-cell lymphocyte count of \< 5 x 10\^9/L who have evidence of lymphadenopathy will be classified as SLL; patients with a peripheral blood B-cell lymphocyte count \>= 5 x 10\^9/L will be considered to have CLL
• Before diagnosing MBL, CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescence in situ hybridization (FISH) analysis for t(11;14)(IgH/cyclin D 1 \[CCND1\]) on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D1 on involved tissue biopsy
• CLL or SLL patients only (does not apply to MBL patients): Rai stage 0-1 (both CLL and SLL patients can be staged using the Rai system)
• Patients must not previously have received the Prevnar 13 pneumococcal vaccination; NOTE: previous vaccination with Pneumovax (PCV23) is permitted but must have been at least 365 days prior to registration
• Patients must be previously untreated and must NOT have any of the following indications for chemotherapy:

You may not qualify if:

• Palpable lymph nodes \> 3 cm in maximal dimension
• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Any of the following comorbid conditions:
• New York Heart Association classification III or IV cardiovascular disease
• Recent myocardial infarction (=\< 30 days)
• Uncontrolled infection
• Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
• Other active primary malignancy requiring treatment or limiting survival to =\< 2 years prior to registration
• Any radiation therapy =\< 28 days prior to registration
• Any major surgery =\< 28 days prior to registration
• Current use of corticosteroids; EXCEPTION: low doses of steroids (=\< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of nonhematologic medical conditions; NOTE: previous use of corticosteroids is allowed
• Active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; NOTE: patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Lenalidomide; 13-valent pneumococcal 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)

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

Results Point of Contact

• Title: Tait D. Shanafelt, MD
• Organization: Mayo Clinic

shanafelt.tait@mayo.edu

507.284.2511

Study Officials

• Tait Shanafelt

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: June 11, 2015
• Primary Completion: April 28, 2017
• Study Completion: July 21, 2017
• Last Updated: January 19, 2021
• Results First Posted: January 19, 2021

Record last verified: 2020-06

Locations

US (3)