B cell non-Hodgkin lymphoma, Post-transplant Lymphoproliferative Disorders, Idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Conditions
Interventions
None listed
Sponsors
Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult patients who have received rituximab/obinutuzumab for hematological diseases (B-cell non-Hodgkin's lymphoma, B-cell lymphoproliferative disease under immunosuppressive conditions, chronic idiopathic thrombocytopenic purpura, acquired thrombocytopenic purpura) 2) Patients who are willing to receive SARS-CoV-2 vaccination initiated by the Japanese government or local government. 3) Patients who have given written consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Patients whom the principal investigator or sub-investigator judges to be inappropriate for participation in the study 2) Patients who have previously received rituximab for non-hematological diseases (polyangiitis granulomatosa, microscopic polyangiitis, refractory nephrotic syndrome) 3) Patients with a history of COVID-19 4) Patients with a history of or coexistence with autoimmune diseases other than chronic idiopathic thrombocytopenic purpura (systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis/polymyositis, mixed connective tissue disease, systemic scleroderma, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, spondyloarthritis and related diseases, vasculitis syndrome, inflammatory bowel disease, Guillain-Barre syndrome, multiple sclerosis, neuromyelitis optica) 5) Patients who are unable to communicate with others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the rate of SARS-CoV-2 IgG antibody positivity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be SARS-CoV-2 IgG antibody titer, peripheral blood lymphocyte fraction, IgG, IgA, IgM, and presence and content of post-vaccination adverse reactions. | — |
Countries
Japan
Contacts
Public ContactMasashi Nishikubo
Kobe City Medical Center General Hospital Department of Hematology
Outcome results
None listed