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

NCT06049134 | Active Not Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 2023-0590NCI-2023-07264
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  through study completion; an average of 1 year

Study Arms (2)

Arm Group A (PCV20)

EXPERIMENTAL

Participants will receive 1 dose of the vaccine

Biological: PCV20

Arm Group B (PCV20)

EXPERIMENTAL

Participants will receive 2 doses of the vaccine

Biological: PCV20

Interventions

PCV20 BIOLOGICAL

Given by Injection into the muscle

Arm Group A (PCV20); Arm Group B (PCV20)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Fareed Khawaja, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: October 6, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)