Primary Immune Thrombocytopenia
Conditions
Interventions
Experimental group:A low dose of daratumumab 8mg/kg was given intravenously weekly for 8 weeks (a total of 8 doses).
Sponsors
the First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. Patients with secondary thrombocytopenia diagnosed by bone marrow cytology except for other diseases; 3. Consistent with refractory ITP diagnosis: Patients with platelet counts less than 30×109/L who were diagnosed with ITP after diagnostic reevaluation were treated with first-line (glucocorticoid ineffective or dependent, gammaglobulin ineffective), second-line thrombopoietic drugs or rituximab ineffective (including rituximab relapse after treatment), or ineffective splenectomy/postoperative relapse; 4. Other anti-ITP treatments were allowed, but only glucocorticoids and TPO-RA were used, and the dose should be stabilized for 2 weeks before enrollment; No increase in dose is allowed during the study; 5.ECOG score =2 points; 6. The condition is relatively stable, WHO bleeding rating 0-1; 7. Fertile women must consent to the use of highly effective contraception from the screening period until 30 days after stopping treatment, the subject must not be breastfeeding, and the pregnancy test is negative; 8. Male subjects with fertile female partners must consent to the use of highly effective contraception from the screening period until 30 days after stopping treatment; 9. No history of mental illness; 10. Voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. The patient has life-threatening bleeding (such as central nervous system bleeding); 2. Uncontrolled infections or infections that require intravenous antibiotic treatment; 3. Received chemotherapy, anticoagulant therapy or other drugs that affect platelet count within 3 months before enrollment; 4. Receiving high doses of corticosteroids or IVIG within 3 months prior to enrollment; 5. There is a serious disease other than ITP (lung, liver or kidney disease); 6. Combined with severe cardiac insufficiency or related diseases that seriously affect cardiac function (such as unstable angina pectoris, congestive heart failure, uncontrolled hypertension, or arrhythmia); 7. Patients diagnosed with other autoimmune diseases through medical history and laboratory tests (such as positive anti-nuclear antibodies, positive anti-cardiolipin antibodies, positive lupus anticoagulants or positive direct Coombs tests); 8. Patients currently co-infected with HIV, active viral hepatitis B or C; 9. Other conditions in which the investigator considered the patient inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete reaction rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| response time;Duration of reaction; | — |
Countries
China
Contacts
Public ContactChangcheng Zheng
the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Outcome results
None listed