Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Conditions
Brief summary
Assessment of SARS-CoV2 (mRNA and adenovirus-based vaccines) and Conjugated Pneumococcal (PCV13) in Patients with Chronic Lymphocytic Leukemia
Interventions
BIOLOGICALPCV13 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
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion/
Exclusion criteria
* 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): * 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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective immune response (EIR) to PCV13 vaccination | 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 | 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. |
Countries
United States
Outcome results
None listed