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Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

ConditionsChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeema Bhat

About this trial

This phase II trial compares the effect of initial vaccination (PCV20 followed by PSV23) with yearly vaccinations of PSV23 to the standard 5 year vaccination in patients with chronic lymphocytic leukemia. At present chronic lymphocytic leukemia patients are poorly protected by anti-pneumococcal vaccination. Current vaccination schedule for chronic lymphocytic leukemia patients is based on general recommendations in immunocompromised patients (initial vaccination with PCV13 followed by one dose of PSV23 after an interval of two months, followed by revaccination at 5 years). Giving patients frequent immunization as compared to 5 year immunization may result in higher protective titers in patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women >= 18 years of age

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

Treatment naive CLL/SLL; No prior therapy for CLL/SLL, including chemotherapy and/or radiotherapy is allowed

Estimated life expectancy of greater than 24 months

Disqualifiers

Patients with neutropenic (granulocyte [PMN]s < 500 cells/mm^3) or having received rituximab within 6 months

Patients with fever (temperature > 38 degrees Celsius [C]) within 1 week

Active infection, recent infection requiring systemic treatment that was completed =< 14 days before starting treatment on the study

Patients with known human immunodeficiency virus (HIV) infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pneumococcal 20-valent Conjugate Vaccine

    Biological/Vaccine

    Given IM

  • Pneumococcal Polyvalent Vaccine

    Biological/Vaccine

    Given IM

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Arm A (Standard ARM- No Booster)Active comparator 1 intervention
Group B: Arm B (Experimental ARM-No Booster)Experimental treatment 2 interventions
Group C: Arm C (Experimental ARM-Annual Booster)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year)

Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19 F and 23F using the enzyme-linked immunosorbent assay (ELISA) method.

Time frame
At 2 years

Secondary outcomes

1

Proportion of patients with anti-pneumococcal immunogenicity

Time frame
At 5 years
2

Proportion of patients with local and/or general reaction

Time frame
At 1 and 3 months
3

Number of pneumococcal infections

Time frame
At 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seema Bhat

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov
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