C91.1 C90.0 C34.9 C82.9 C83.0 C83.1 C83.3
Conditions
Interventions
Group 1: We will include patients with one of the following diagnoses (and therapies):
B-cell Non-Hodgkin’s lymphoma (Follicular lymphoma, Mantle cell lymphoma, Marginal zone lymphoma, Diffuse large B
B-cell Non-Hodgkin’s lymphoma less than 6 months after therapy with anti-CD20 monoclonal antibodies (Rituximab, Obinutuzumab)
B-cell Non-Hodgkin’s lymphoma 6 - 60 months after therapy with anti-CD20 monoclonal antibodies
Chronic lymphathic leukemia with Bruton´s tyrosine kinase- or BCL-2-inhibition (Venetoclax, Ibrutinib)
Multiple Myeloma (“watch & wait”
treatment with Lenalidomide, Bortezomib
Daratumumab, Ixazomib, Carfilzomib)
Non Small Cell Lung Cancer (NSCLC) under PD1/PD-L1-checkpoint inhibition (Durvalumab, Pembrolizumab, Nivolumab).
Blood samples will by taken 1-14 days before the first vaccination against SARS-CoV-2,
Sponsors
Medizin I, Universitätsklinik Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must not have received any prior COVID-19 vaccination and have one of the following diagnosis (and therapy): B-cell Non-Hodgkin’s lymphoma (Follicular lymphoma, Mantle cell lymphoma, Marginal zone lymphoma, Diffuse large B-cell lymphoma, Chronic lymphatic leukemia) without treatment (“watch-and-wait”); B-cell Non-Hodgkin’s lymphoma less than 6 months after therapy with anti-CD20 monoclonal antibodies (Rituximab, Obinutuzumab); B-cell Non-Hodgkin’s lymphoma 6 - 60 months after therapy with anti-CD20 monoclonal antibodies; Chronic lymphathic leukemia with Bruton´s tyrosine kinase- or BCL-2-inhibition (Venetoclax, Ibrutinib); Multiple Myeloma (“watch & wait”; treatment with Lenalidomide, Bortezomib; Daratumumab, Ixazomib, Carfilzomib); Non Small Cell Lung Cancer (NSCLC) under PD1/PD-L1-checkpoint inhibition (Durvalumab, Pembrolizumab, Nivolumab)
Exclusion criteria
Exclusion criteria: refusal to participate; additional immunosuppressive therapy i.e. chemotherapy; patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons; persons who can not give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity of COVID-19 vaccination (2)-8 weeks after second vaccination as confirmed by the presence of anti-SARS-CoV-2-spike-specific antibodies (+ anti-NC-antibodies to assess previous COVID-19) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity of COVID-19 vaccination (2)-8 weeks after second vaccination as confirmed by the presence of SARS-CoV-2 -specific CD4+ T cells; immunogenicity of COVID-19 vaccination (2)-8 weeks after second vaccination as confirmed by the presence of neutralizing antibodies against SARS-CoV-2 wildtype (D614G); immunogenicity of the COVID-19 vaccination (2)-8 weeks after second vaccination as confirmed by the presence of neutralizing antibodies against different VOC PANGO lineages of SARS-CoV-2 (e.g., B.1.1.7, B1.351, P.1, B.1.617); immunogenicity of COVID-19 vaccination 6, 12 and 18 months (+/- 2 weeks) after first vaccination as confirmed by the presence of anti-SARS-CoV-2-specific antibodies; differences in humoral and cellular immunogenicity in our patients with malignant pathologies within the different hematologic malignancies and between the treatments. | — |
Countries
Germany
Contacts
Public ContactAndrea Hafkemeyer
Medizin I, Universitätsklinik Freiburg
Outcome results
None listed