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Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy

Primary Purpose

Lymphoma

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PCV20
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma

Eligibility Criteria

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

Inclusion Criteria: Patients who have a history of non-Hodgkin B-cell lymphoma and whose disease has been in remission for at least 1 year. Patients who received any anti-CD20 therapy at any time during their treatment for B-cell lymphoma. Patients who are at least 18 years of age. Patients who can provide consent; no legal authorized representative will be able to provide consent on a patient's behalf. Exclusion Criteria: Patients who have received cellular therapy, including chimeric antigen receptor T-cell therapy or any type of hematopoietic cell transplantation. Patients who have received PCV or pneumococcal polysaccharide vaccine within 5 years of screening for enrollment. Patients who are unable to attend follow-up appointments at designated times at MD Anderson. Any vulnerable population patient ((children, pregnant women, cognitively impaired adults, or prisoners)

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm Group A (PCV20)

Arm Group B (PCV20)

Arm Description

Participants will receive 1 dose of the vaccine

Participants will receive 2 doses of the vaccine

Outcomes

Primary Outcome Measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
October 6, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT06049134
Brief Title
Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy
Official Title
Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the effects of a pneumococcal vaccine called PCV20 when given as a single dose versus a boosted regimen to patients who previously received anti-CD20 therapy as treatment for B cell lymphoma.
Detailed Description
Primary Objectives: --Compare the humoral responses in terms of difference in IgG titers at 1 month from routine single dose PCV20 or a boosted PCV20 regimen in B cell lymphoma survivors who previously received treatment with anti-CD20 therapy. Secondary Objectives: Compare the humoral responses in terms of difference in IgG titers at 3, 6 and12 from routine single dose PCV20 or a boosted PCV20 regimen in B cell lymphoma survivors who previously received treatment with anti-CD20 therapy. Estimate the rate of pneumonia (all bacterial pneumonia including pneumococcal pneumonia) within a year from routine single dose PCV20 or a boosted PCV20 regimen in lymphoma survivors who previously received treatment with anti-CD 20 therapy. Correlate humoral responses to development of bacterial pneumonia and pneumococcal pneumonia and with severity of this infection in lymphoma survivors within a year of vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm Group A (PCV20)
Arm Type
Experimental
Arm Description
Participants will receive 1 dose of the vaccine
Arm Title
Arm Group B (PCV20)
Arm Type
Experimental
Arm Description
Participants will receive 2 doses of the vaccine
Intervention Type
Biological
Intervention Name(s)
PCV20
Intervention Description
Given by Injection into the muscle
Primary Outcome Measure Information:
Title
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time Frame
through study completion; an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have a history of non-Hodgkin B-cell lymphoma and whose disease has been in remission for at least 1 year. Patients who received any anti-CD20 therapy at any time during their treatment for B-cell lymphoma. Patients who are at least 18 years of age. Patients who can provide consent; no legal authorized representative will be able to provide consent on a patient's behalf. Exclusion Criteria: Patients who have received cellular therapy, including chimeric antigen receptor T-cell therapy or any type of hematopoietic cell transplantation. Patients who have received PCV or pneumococcal polysaccharide vaccine within 5 years of screening for enrollment. Patients who are unable to attend follow-up appointments at designated times at MD Anderson. Any vulnerable population patient ((children, pregnant women, cognitively impaired adults, or prisoners)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fareed Khawaja, MD
Phone
(281) 610-0253
Email
fkhawaja@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fareed Khawaja, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fareed Khawaja, M D
Phone
281-610-0253
Email
fkhawaja@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Fareed Khawaja, M D

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy

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