hematooncological diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: patients • age = 18 years • one of the following malignant diagnoses: - myeloid disorders (AML, MPN, or MDS) - lymphatic disorders (CLL, lymphoma, or MM) - malignant diseases treated with checkpoint inhibitors healthy subjects • age = 18 Jahre • willingness to or present appointment for covid-19 vaccination
Exclusion criteria
Exclusion criteria: patients • patients not willing to or unable to get vaccinated • patients with a duration of remission of = 5 years • patients unable to give consent healthy subjects • subjects not willing to or unable to get vaccinated according to recommendations of the Robert-Koch-Institut • subjects with a malignant disease and a duration of remission of < 5 years • subjects unable to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| humoral immune response to the covid-19 vaccine of patients with hemato-oncological diseases compared to healthy subjects on day 35 (+7) after initial vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| • humoral immune status: - before covid-19 vaccination (day 0 to -21) - day 120 (+14) after initial vaccination • cellular immune status before, on day 35 (+7) and day 120 (+14) after initial vaccination • immune response of hemato-oncological diseases: - myeloid disorders [acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN) and myelodysplastic syndromes (MDS)] - lymphatic disorders [chronic lymphocytic leukemia (CLL), lymphoma, multiple myeloma (MM)] - patients currently treated with checkpoint inhibitors • immune response of therapy versus „watch and wait“ • impact of patient and disease related factors on immune response • CRP and lymphocyte count in peripheral blood • post-marketing surveillance for collection of safety and tolerability data of the covid-19 vaccine in patients with hemato-oncological diseases and healthy subjects | — |
Countries
Germany
Contacts
Krukenberg Krebszentrum HalleUniversitätsklinikum Halle (Saale)