Immune thrombocytopenia
Conditions
Interventions
experimental group:Zanubrutinib combined with Cyclosporin
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age = 18 years old; 2) Consistent with the diagnosis of persistent or chronic immune thrombocytopenia (ITP); 3) Two consecutive platelet counts below 30 * 10E9/L (with at least one day interval between them); 4) According to the definition of refractory ITP, it refers to patients who are ineffective in first-line treatment drugs (glucocorticoids and/or intravenous immunoglobulin), platelet promoting drugs or rituximab in second-line treatment, or who have ineffective splenectomy or postoperative recurrence; 5) This study allows patients to combine and use other drugs for the treatment of ITP, with specific provisions as follows: • Glucocorticoids: within at least 2 weeks prior to the first study medication, it is allowed to use = 20mg/day of prednisone or other equivalent doses of glucocorticoids, with the dosage maintained or regularly reduced; Danazol: The dosage remained unchanged for the first three months prior to the first study medication; Alternatively, danazol may have been discontinued for at least 2 weeks prior to the first study medication; Immunosuppressants (including azathioprine, cyclosporine A, mycophenolate mofetil, etc.): Immunosuppressants have been discontinued for at least 2 weeks prior to the first study medication; • TPO receptor agonists (such as Eltrombopag, Hetrombopag, Avatrombopag): The dosage remains unchanged for 4 weeks prior to the first study medication; Alternatively, TPO receptor agonists may have been discontinued for at least 2 weeks prior to the first study medication. 6) Good liver and kidney function (ALT = 2 * ULN, AST = 2 * ULN, total bilirubin = 1.5 * ULN; creatinine<176) µ mol/L); 7) Be aware and voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1) Secondary immune thrombocytopenia (such as in patients with HIV, HCV, Helicobacter pylori infection, or systemic lupus erythematosus); 2) Serious life-threatening bleeding (such as cerebral hemorrhage, gastrointestinal bleeding, etc.); 3) Received intravenous immunoglobulin, high-dose dexamethasone, or high-dose methylprednisolone therapy within 2 weeks prior to the first study medication; 4) Received treatment with recombinant human thrombopoietin (rhTPO) or Romiplostim within 2 weeks prior to the first study medication; 5) Received splenectomy treatment within 12 weeks prior to the first study medication; 6) Received treatment with rituximab within six months prior to the first study medication; 7) Any active malignant tumor, except for focal non metastatic squamous cell or basal cell skin cancer or in situ cancer; Patients with a history of malignant tumors but who have been cured (such as evidence of no malignant tumors within at least 2 years) can be enrolled; 8) There are other clinically significant, poorly controlled, and treatable systemic infections (viral, bacterial, or fungal); 9) Pregnant or lactating women; Or plan to conceive during the study period; 10) Existence of severe heart disease, including New York Heart Association (NYHA) grade III or IV congestive heart failure, uncontrolled hypertension or hypotension, or severe valve or endocardial disease, or significant history of kidney, nervous system, mental, endocrine, metabolic, immune, liver, cardiovascular and cerebrovascular diseases, or any other medical condition that the researcher believes may have adverse effects on the participant in the study; 11) The subject has malabsorption syndrome or other adverse conditions that hinder the intestinal administration route; 12) Has a history of coagulation disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactMai Wenyuan
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed