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

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ClinicalTrials.gov Identifier: NCT06049134
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: PCV20 Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy
Actual Study Start Date : October 6, 2023
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : July 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm Group A (PCV20)
Participants will receive 1 dose of the vaccine
 Biological: PCV20
Given by Injection into the muscle
Experimental: Arm Group B (PCV20)
Participants will receive 2 doses of the vaccine
 Biological: PCV20
Given by Injection into the muscle


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who have a history of non-Hodgkin B-cell lymphoma and whose disease has been in remission for at least 1 year.
  2. Patients who received any anti-CD20 therapy at any time during their treatment for B-cell lymphoma.
  3. Patients who are at least 18 years of age.
  4. Patients who can provide consent; no legal authorized representative will be able to provide consent on a patient's behalf.

Exclusion Criteria:

  1. Patients who have received cellular therapy, including chimeric antigen receptor T-cell therapy or any type of hematopoietic cell transplantation.
  2. Patients who have received PCV or pneumococcal polysaccharide vaccine within 5 years of screening for enrollment.
  3. Patients who are unable to attend follow-up appointments at designated times at MD Anderson.
  4. Any vulnerable population patient ((children, pregnant women, cognitively impaired adults, or prisoners)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049134


Contacts
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Contact: Fareed Khawaja, MD (281) 610-0253 fkhawaja@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Fareed Khawaja, M D    281-610-0253    fkhawaja@mdanderson.org   
Principal Investigator: Fareed Khawaja, M D         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Fareed Khawaja, MD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT06049134    
Other Study ID Numbers: 2023-0590
NCI-2023-07264 ( Other Identifier: NCI-CTRP Clinical Trials Gov )
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2024

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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
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases