immune thrombocytopenic purpura
Conditions
Interventions
Experimental Group: CD20 monoclonal antibody combined with TPO-RA
Control Group:splenectomy
Control Group:TPO-RA
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age < 75 years old; 2.According to the 2020 Chinese Guidelines of Primary Immune Thrombocytopenia in Adults, those who meet the following 4 requirements: (1) At least 2 consecutive blood routine examinations show a decrease in platelet count, and there is no obvious abnormality in morphology of peripheral blood cells under smear microscopy; (2) The spleen is generally not enlarged; (3) Bone marrow examination: the morphological features of bone marrow cells in ITP patients are increased or normal in the number of megakaryocytes, but with maturation disorders; (4) Other secondary thrombocytopenias should be excluded: autoimmune disease, thyroid diseases, lymphoproliferative diseases, myelodysplastic syndromes, aplastic anemia, various hematological malignancies, tumor infiltration, chronic liver diseases, hypersplenism, common variant immunodeficiency diseases, acute and chronic infections ( Including Helicobacter pylori infection), vaccination, platelet consumption reduction, drug-induced thrombocytopenia, alloimmune thrombocytopenia, gestational thrombocytopenia, congenital thrombocytopenia and pseudothrombocytopenia etc. 3.Platelets count below 20×109/L; 4.The staging of the disease is: (1) Persistent ITP: persistent thrombocytopenia for 3-12 months after diagnosis, including patients who have not spontaneously remitted and who cannot maintain complete remission after stopping treatment; (2) chronic ITP: persistent platelet count reduce for more than 12 months; 5.No current infection, hepatitis B DNA <103, hepatitis C RNA (-); 6.Exclude tuberculosis infection. If there is evidence of tuberculosis infection in the past, preventive anti-tuberculosis treatment should be given on the basis of consultation with the infectious disease department; 7.No history of spleenectomy or CD20 monoclonal antibody treatment in the past; 8.No severe heart, liver and kidney insufficiency; 9.Each patient (or his or her legal representative) must sign an informed consent form (ICF), indicating that he / she understands the purpose and procedures of the study and is willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Severe dysfunction of heart, kidney, liver and lung; severe immune deficiency; 2.Pregnancy or lactation; 3.Myelofibrosis; 4.Mental illness that may prevent subjects from completing treatment or informed consent;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR) rate;Response rate;No response rate;Recurrence rate;Duration of response; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to reaction; | — |
Countries
China
Contacts
Public ContactZhen Cai
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed