Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaNCT05007860
Vaccine Responsiveness in Patients With Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Assessment of SARS-CoV2 (mRNA and adenovirus-based vaccines) and Conjugated Pneumococcal (PCV13) in Patients with Chronic Lymphocytic Leukemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- What is being tested?
- PCV13 vaccine and any of the FDA-approved COVID-19 vaccine products (BNT162b2, mRNA-1273, or Ad26.COV2.S) based on local availability.
- Type of treatment
- Vaccines
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patients with CLL/SLL receiving PCV13 +/- COVID19 vaccination.
Who may be able to join
- Age >18 years.
- Diagnosis of CLL or SLL according to WHO criteria.
- For patients receiving BTK inhibitor (Cohorts 1 and 2):
- Patient must have no history of cytotoxic chemotherapy within 1 year (no prior history of bendamustine or fludarabine is permitted) and no history of CD20 monoclonal antibody within 6 months.
- Patient must have no known clinical or radiographic evidence of CLL progression.
- For patients not on active therapy (Cohort 3):
Show all 10Show fewer
- Patient must have no history of cytotoxic chemotherapy within 1 year (no prior history of bendamustine or fludarabine is permitted) and no history of CD20 monoclonal antibody within 6 months.
- The treating investigator must have no intention to initiate CLL therapy within 2 months.
- Patients must have not received PCV13 within 2 years. For patients with PCV13 within 5 years, S. pneumonia IgG antibody concentrations must be less than the reference value for at least 50% of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,19F and 23F. Patients can have received prior PPV23 within any time frame.
- Patient must have no known history of HIV or primary immune deficiency disorder, nor be taking a concurrent immune suppressing medication (e.g. steroids, methotrexate, etc.).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
Assessment of SARS-CoV2 (mRNA and adenovirus-based vaccines) and Conjugated Pneumococcal (PCV13) in Patients with Chronic Lymphocytic Leukemia
- Being tested
- PCV13 vaccine and any of the FDA-approved COVID-19 vaccine products (BNT162b2, mRNA-1273, or Ad26.COV2.S) based on local availability.
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV13 vaccine and any of the FDA-approved COVID-19 vaccine products (BNT162b2, mRNA-1273, or Ad26.COV2.S) based on local availability.Biological
Vaccines administered per standard of care
| Study group | Role | What they receive |
|---|---|---|
| No active therapy | Age ≥18 years and CLL/SLL (WHO criteria). We excluded patients with known HIV or primary immune deficiency disorder, known active progression of CLL/SLL, active therapy, treating physician intent to initiate CLL/SLL therapy within ≤2 months, prior cytotoxic chemotherapy within ≤1 year, CD20 monoclonal Ab within ≤6 months, or any prior bendamustine or fludarabine. We excluded patients who received PCV13 within ≤2 years, or within 2-5 years with nonprotective titers for ≥50% of PCV13-specific S. pneumonia IgG titers. Receives: Biological: PCV13 vaccine and any of the FDA-approved COVID-19 vaccine products (BNT162b2, mRNA-1273, or Ad26.COV2.S) based on local availability. | |
| BTK inhibitor therapy (continued) | Age ≥18 years, CLL/SLL (WHO criteria), and active therapy with a BTK inhibitor which is continued through vaccination. We excluded patients with known HIV or primary immune deficiency disorder, known active progression of CLL/SLL, prior cytotoxic chemotherapy within ≤1 year, CD20 monoclonal Ab within ≤6 months, or any prior bendamustine or fludarabine. We excluded patients who received PCV13 within ≤2 years, or within 2-5 years with nonprotective titers for ≥50% of PCV13-specific S. pneumonia IgG titers. Receives: Biological: PCV13 vaccine and any of the FDA-approved COVID-19 vaccine products (BNT162b2, mRNA-1273, or Ad26.COV2.S) based on local availability. | |
| BTK inhibitor therapy (interrupted) | Age ≥18 years, CLL/SLL (WHO criteria), and active therapy with a BTK inhibitor which is interrupted at time of vaccination. We excluded patients with known HIV or primary immune deficiency disorder, known active progression of CLL/SLL, prior cytotoxic chemotherapy within ≤1 year, CD20 monoclonal Ab within ≤6 months, or any prior bendamustine or fludarabine. We excluded patients who received PCV13 within ≤2 years, or within 2-5 years with nonprotective titers for ≥50% of PCV13-specific S. pneumonia IgG titers. Receives: Biological: PCV13 vaccine and any of the FDA-approved COVID-19 vaccine products (BNT162b2, mRNA-1273, or Ad26.COV2.S) based on local availability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective immune response (EIR) to PCV13 vaccination
EIR is defined as a >2-fold increase or conversion from a nonprotective to a protective titer for >50% of specific S. pneumonia IgG titers (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) vs baseline.
Measured: 35 days (+/- 14 days) after vaccination
Effective immune response (EIR) to COVID19 vaccination
EIR is defined as a >4-fold increase from baseline, or seroconversion defined as change from negative to within the measuring interval, for specific SARS-CoV-2 antibody titers (spike protein). For patients without pre-COVID-19 vaccination.
serology, a negative post-COVID-19 vaccination nucleocapsid antibody titer will be used as a surrogate for no prior infection and in this case a post-COVID-19 vaccination spike antibody titer within the measuring interval will be interpreted as an EIR.
Measured: 35 days (+/- 14 days) after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start16 Jul 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Soumerai, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007860
- Sponsor's protocol ID
- 20-296
- Status last verified
- Jul 2023
- First submitted
- 9 Aug 2021
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected for the study, including individual deidentified participant data and a data dictionary defining each field in the set, will be made available at study closeout.
Publications
Haydu JE, Maron JS, Redd RA, Gallagher KME, Fischinger S, Barnes JA, Hochberg EP, Johnson PC, Takvorian RW, Katsis K, Portman D, Ruiters J, Sechio S, Devlin M, Regan C, Blumenthal KG, Banerji A, Judd AD, Scorsune KJ, McGree BM, Sherburne MM, Lynch JM, Weitzman JI, Lei M, Kotton CN, Dighe AS, Maus MV, Alter G, Abramson JS, Soumerai JD. Humoral and cellular immunogenicity of SARS-CoV-2 vaccines in chronic lymphocytic leukemia: a prospective cohort study. Blood Adv. 2022 Mar 22;6(6):1671-1683. doi: 10.1182/bloodadvances.2021006627.
PubMed 35073571
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Responsiveness in Patients With Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT05007860
- Acronym / sponsor ID
- 20-296
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Aug 2021 (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.
Assessment of SARS-CoV2 (mRNA and adenovirus-based vaccines) and Conjugated Pneumococcal (PCV13) in Patients with Chronic Lymphocytic Leukemia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No active therapy | – | Biological: PCV13 vaccine and any of the FDA-approved COVID-19 vaccine products (BNT162b2, mRNA-1273, or Ad26.COV2.S) based on local availability.Age ≥18 years and CLL/SLL (WHO criteria). We excluded patients with known HIV or primary immune deficiency disorder, known active progression of CLL/SLL, active therapy, treating physician intent to initiate CLL/SLL therapy within ≤2 months, prior cytotoxic chemotherapy within ≤1 year, CD20 monoclonal Ab within ≤6 months, or any prior bendamustine or fludarabine. We excluded patients who received PCV13 within ≤2 years, or within 2-5 years with nonprotective titers for ≥50% of PCV13-specific S. pneumonia IgG titers. |
| BTK inhibitor therapy (continued) | – | Biological: PCV13 vaccine and any of the FDA-approved COVID-19 vaccine products (BNT162b2, mRNA-1273, or Ad26.COV2.S) based on local availability.Age ≥18 years, CLL/SLL (WHO criteria), and active therapy with a BTK inhibitor which is continued through vaccination. We excluded patients with known HIV or primary immune deficiency disorder, known active progression of CLL/SLL, prior cytotoxic chemotherapy within ≤1 year, CD20 monoclonal Ab within ≤6 months, or any prior bendamustine or fludarabine. We excluded patients who received PCV13 within ≤2 years, or within 2-5 years with nonprotective titers for ≥50% of PCV13-specific S. pneumonia IgG titers. |
| BTK inhibitor therapy (interrupted) | – | Biological: PCV13 vaccine and any of the FDA-approved COVID-19 vaccine products (BNT162b2, mRNA-1273, or Ad26.COV2.S) based on local availability.Age ≥18 years, CLL/SLL (WHO criteria), and active therapy with a BTK inhibitor which is interrupted at time of vaccination. We excluded patients with known HIV or primary immune deficiency disorder, known active progression of CLL/SLL, prior cytotoxic chemotherapy within ≤1 year, CD20 monoclonal Ab within ≤6 months, or any prior bendamustine or fludarabine. We excluded patients who received PCV13 within ≤2 years, or within 2-5 years with nonprotective titers for ≥50% of PCV13-specific S. pneumonia IgG titers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with CLL/SLL receiving PCV13 +/- COVID19 vaccination.
Key inclusion criteria (10 listed)
- Age >18 years.
- Diagnosis of CLL or SLL according to WHO criteria.
- For patients receiving BTK inhibitor (Cohorts 1 and 2):
- For patients not on active therapy (Cohort 3):
- Patients must have not received PCV13 within 2 years. For patients with PCV13 within 5 years, S. pneumonia IgG antibody concentrations must be less than the reference value for at least 50% of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,19F and 23F. Patients can have received prior PPV23 within any time frame.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PCV13 vaccine and any of the FDA-approved COVID-19 vaccine products (BNT162b2, mRNA-1273, or Ad26.COV2.S) based on local availability.Vaccines administered per standard of care | Biological | BTK inhibitor therapy (continued), BTK inhibitor therapy (interrupted), No active therapy |
Primary outcome
Effective immune response (EIR) to PCV13 vaccination
Time frame: 35 days (+/- 14 days) after vaccination
EIR is defined as a >2-fold increase or conversion from a nonprotective to a protective titer for >50% of specific S. pneumonia IgG titers (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) vs baseline.
Effective immune response (EIR) to COVID19 vaccination
Time frame: 35 days (+/- 14 days) after vaccination
EIR is defined as a >4-fold increase from baseline, or seroconversion defined as change from negative to within the measuring interval, for specific SARS-CoV-2 antibody titers (spike protein). For patients without pre-COVID-19 vaccination. serology, a negative post-COVID-19 vaccination nucleocapsid antibody titer will be used as a surrogate for no prior infection and in this case a post-COVID-19 vaccination spike antibody titer within the measuring interval will be interpreted as an EIR.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Derived from this study: PubMed 35073571Haydu JE, Maron JS, Redd RA, Gallagher KME, Fischinger S, Barnes JA, Hochberg EP, Johnson PC, Takvorian RW, Katsis K, Portman D, Ruiters J, Sechio S, Devlin M, Regan C, Blumenthal KG, Banerji A, Judd AD, Scorsune KJ, McGree BM, Sherburne MM, Lynch JM, Weitzman JI, Lei M, Kotton CN, Dighe AS, Maus MV, Alter G, Abramson JS, Soumerai JD. Humoral and cellular immunogenicity of SARS-CoV-2 vaccines in chronic lymphocytic leukemia: a prospective cohort study. Blood Adv. 2022 Mar 22;6(6):1671-1683. doi: 10.1182/bloodadvances.2021006627.
- Individual participant dataSharing planned: Yes. All data collected for the study, including individual deidentified participant data and a data dictionary defining each field in the set, will be made available at study closeout.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Massachusetts General Hospital 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 10 inclusion and 0 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: finished, as of the sponsor's last update on 7 Jul 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effective immune response (EIR) to PCV13 vaccination (time frame: 35 days (+/- 14 days) after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007860, which also lists 1 linked publication.
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 7 Jul 2023.