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Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pneumococcal 13-valent Conjugate Vaccine
Pneumococcal Polyvalent Vaccine
Sponsored by
Seema Bhat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of allergic reactions attributable to compounds of similar chemical or biologic composition to any component of pneumococcal vaccines
  • Chemotherapy in 4 weeks
  • Patients who have previously received pneumococcal vaccine within the preceding 12 months
  • Absolute lymphocyte count less than 500 cells/mm^3
  • Patient with other severe immune deficiency
  • Patients may not be receiving any other investigational agents
  • Active malignancy from which the subject is considered by his or her physician to have a less than 5-year survival expectation
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and/or psychiatric illness/social situations that would limit compliance with study requirements
  • Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 20 mg/day of prednisone) within 14 days of the first dose of study drug
  • 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
  • Unwilling or unable to participate in all required study evaluations and procedures
  • Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)

Sites / Locations

  • Ohio State University Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (yearly booster)

Arm B (5 year booster)

Arm Description

Patients receive PCV13 IM at week 1 and PSV23 IM at week 8. Patients then receive PSV23 IM booster at years 1, 2, 3, 4 and 5.

Patients receive PCV13 IM at week 1 and PSV23 IM at week 8. Patients then receive PSV23 IM booster at year 5.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of patients with anti-pneumococcal immunogenicity
Proportion of patients with local and/or general reaction
Number of pneumococcal infections

Full Information

First Posted
June 9, 2022
Last Updated
October 23, 2023
Sponsor
Seema Bhat
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1. Study Identification

Unique Protocol Identification Number
NCT05417165
Brief Title
Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia
Official Title
Phase II Comparative Study of Anti-Pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seema Bhat

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial compares the effect of initial vaccination (PCV13 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.
Detailed Description
PRIMARY OBJECTIVE: I. Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year) at 2 years (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). SECONDARY OBJECTIVES: I. Number of patients with anti-pneumococcal immunogenicity at 5 years. II. Number of patients with local and/or general reaction at months 1, 3 as self-reported. III. Number of pneumococcal infections. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive pneumococcal 13-valent conjugate vaccine (PCV13) intramuscularly (IM) at week 1 and pneumococcal polyvalent vaccine (PSV23) IM at week 8. Patients then receive PSV23 IM booster at years 1, 2, 3, 4 and 5. ARM B: Patients receive PCV13 IM at week 1 and PSV23 IM at week 8. Patients then receive PSV23 IM booster at year 5.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (yearly booster)
Arm Type
Experimental
Arm Description
Patients receive PCV13 IM at week 1 and PSV23 IM at week 8. Patients then receive PSV23 IM booster at years 1, 2, 3, 4 and 5.
Arm Title
Arm B (5 year booster)
Arm Type
Active Comparator
Arm Description
Patients receive PCV13 IM at week 1 and PSV23 IM at week 8. Patients then receive PSV23 IM booster at year 5.
Intervention Type
Biological
Intervention Name(s)
Pneumococcal 13-valent Conjugate Vaccine
Other Intervention Name(s)
PCV 13, PCV13 Vaccine, Prevnar 13
Intervention Description
Given IM
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Polyvalent Vaccine
Other Intervention Name(s)
PCV 23, Pneumococcal 23-valent Polysaccharide Vaccine, Pneumococcal Polysaccharide Vaccine, Pneumococcal Vaccine Polyvalent, Pneumovax 23, Pnu-Imune 23, PPSV, PPSV23, PPSV23 Vaccine
Intervention Description
Given IM
Primary Outcome Measure Information:
Title
Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year)
Description
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 Outcome Measure Information:
Title
Proportion of patients with anti-pneumococcal immunogenicity
Time Frame
At 5 years
Title
Proportion of patients with local and/or general reaction
Time Frame
At 1 and 3 months
Title
Number of pneumococcal infections
Time Frame
At 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 History of allergic reactions attributable to compounds of similar chemical or biologic composition to any component of pneumococcal vaccines Chemotherapy in 4 weeks Patients who have previously received pneumococcal vaccine within the preceding 12 months Absolute lymphocyte count less than 500 cells/mm^3 Patient with other severe immune deficiency Patients may not be receiving any other investigational agents Active malignancy from which the subject is considered by his or her physician to have a less than 5-year survival expectation Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and/or psychiatric illness/social situations that would limit compliance with study requirements Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 20 mg/day of prednisone) within 14 days of the first dose of study drug 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 Unwilling or unable to participate in all required study evaluations and procedures Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seema A Bhat, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seema A. Bhat, MD
Email
Seema.bhat@osumc.edu
First Name & Middle Initial & Last Name & Degree
Seema A. Bhat, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

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