Primary immune thrombocytopenia
Conditions
Interventions
Experimental group:Orelabrutinib (50 mg qd po) combined with high-dose dexamethasone (40 mg qd for 4 days)
Control group:High-dose dexamethasone (40mg qd*4d)
Sponsors
HenanCancerHospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 - 80 years (inclusive of the threshold value), gender not restricted. 2. Meets the diagnostic criteria for ITP: According to the 2019 American Society of Hematology Clinical Guidelines and/or the 2020 Chinese Guidelines for Diagnosis and Treatment of Adult Primary Immune Thrombocytopenia, it meets the diagnostic criteria for ITP. 3. Under the premise of 2), in addition to meeting: a. During the screening visit and/or before randomization, the average value of two platelet counts is less than 30×10^9/L (with at least a 1-day interval), and there is no single platelet count greater than 35×10^9/L, and there is no active bleeding in any important organ. b. In addition, the peripheral blood smear results should support the diagnosis of ITP, and there is no evidence indicating the cause of other thrombocytopenia (such as pseudo-thrombocytopenia, myelofibrosis, hereditary thrombocytopenia, etc.). Any disease that may cause thrombocytopenia other than ITP. 4. Has not received any drug or surgical intervention that may be effective for ITP treatment before. If the subject has received glucocorticoid administration, but the duration is less than 5 days and the daily glucocorticoid dose is less than the equivalent dose of prednisone (1mg/kg), it can be regarded as a first treatment. 5. For fertile women, they are willing to use highly effective contraceptive methods from the start of the study drug to 90 days after the last dose of the study drug. All male subjects and their female partners need to use highly effective contraceptive measures during the study period and for 90 days after the last administration. 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 7. The patient fully understands and can comply with the requirements of the study protocol and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Primary ITP without a proven diagnosis: a. Positivity for autoimmune markers: Antinuclear antibody (>=1:80), anti-thyroglobulin antibody, anti-thyroid peroxidase antibody, anticardiolipin antibody (>=40 GPL U/mL), anti-ß2-glycoprotein antibody (>=40 IgG) U/mL), lupus anticoagulant (KCT ratio, dRVVT ratio >= 1.5 times the upper limit of normal), direct antiglobulin test; b. Multi-lineage immune cytopenia, such as Evans syndrome, autoimmune pancytopenia; c. Possible triggers of hereditary thrombocytopenia or secondary ITP, Such as untreated Helicobacter pylori infection, leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome, systemic lupus erythematosus, thyroid disease, liver cirrhosis, HIV infection, hepatitis C, antiphospholipid antibody syndrome, drug induced (quinine, heparin, antimicrobial drugs, anticonvulsants, etc.). 2. According to the Adult Primary Immune Thrombocytopenia Bleeding Scoring system, bleeding symptoms due to ICH or gastrointestinal bleeding were scored >=5. 3. History of malignant tumor. Patients who were cured with appropriate treatment before the first dose and had no recurrence for more than 5 years were eligible for inclusion in the study. Nonmelanoma skin cancer in situ (e.g., basal-cell or squamous-cell carcinoma) or carcinoma of the cervix in situ that had been completely surgically removed were eligible. 4. Suffering from severe hypertension or cardiovascular (such as NYHA class III/IV congestive heart failure, atrial fibrillation, angina pectoris, myocardial infarction, coronary stent implantation, angioplasty, coronary artery bypass grafting), digestive, respiratory, renal, hematological, central nervous system diseases, etc. Participants with a medically ill condition that was markedly unstable, not effectively treated, or likely to result in hospitalization; significant, uncontrolled coexisting medical conditions (including poorly controlled diabetes and related medical history); or psychiatric disorders that could affect adherence to the protocol or interpretation of the study results. 5. Gilbert's syndrome or chronic liver disease; Any pre-existing severe liver disease, including but not limited to alcoholic hepatitis and steatosis, severe fatty liver disease, non-alcoholic fatty liver disease, liver cirrhosis, autoimmune hepatitis, or the presence of ascites, hepatic encephalopathy, coagulopathy, hypoproteinemia, esophageal or gastric varices; Preexisting or potential risk factors for abnormal liver function were based on the investigator's judgment. 6. A known history of inflammatory bowel disease, symptomatic diverticulosis, or a confirmed duodenal, gastric, or esophageal ulcer within 6 months before screening; Clinically symptomatic GI bleeding within 6 months before screening (a positive occult blood test without any signs and symptoms of GI bleeding was not considered "clinically symptomatic") and/or a current known risk of clinically relevant GI bleeding outside of gastritis or esophagitis and/or ITP. 7. Deep organ motor bleeding within 4 weeks before screening (at least 6 months from enrollment if intracranial). 8. History of arterial or venous thromboembolism (e.g., stroke, transient ischemic attack, deep-vein thrombosis, or pulmonary embolism) within 6 months before screening. 9. Subjects had a history of other coagulopathy other than ITP, such as disseminated intravascular coagulation, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura, etc. 10. Have active uncontrol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Initial response rate;Complete loss of reaction;Duration of response;Adverse event;Response time; | — |
Countries
China
Contacts
Public ContactHu Zhou
Henan Provincial Cancer Hospital
Outcome results
None listed