LymphomaPhase 4NCT06049134
Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy
A Phase 4 study testing PCV20 in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- PCV20
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- PCV20
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV20Biological
Given by Injection into the muscle
| Study group | Role | What they receive |
|---|---|---|
| Arm Group A (PCV20) | Experimental | Participants will receive 1 dose of the vaccine Receives: Biological: PCV20 |
| Arm Group B (PCV20) | Experimental | Participants will receive 2 doses of the vaccine Receives: Biological: PCV20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start6 Oct 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareed Khawaja, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049134
- Sponsor's protocol ID
- 2023-0590
- Other IDs
- NCI-2023-07264
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy
- ClinicalTrials.gov ID
- NCT06049134
- Acronym / sponsor ID
- 2023-0590
- Conditions
- Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Group A (PCV20) | Experimental | Biological: PCV20Participants will receive 1 dose of the vaccine |
| Arm Group B (PCV20) | Experimental | Biological: PCV20Participants will receive 2 doses of the vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCV20Given by Injection into the muscle | Biological | Arm Group A (PCV20), Arm Group B (PCV20) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fareed Khawaja, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCV20 in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.