Status:
RECRUITING
Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Beijing Children's Hospital
Tianjin Children's Hospital
Conditions:
Immune Thrombocytopenia
Treatment
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treat...
Detailed Description
Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized by decreased platelet count and skin and mucosal bleeding. ITP is a kind of disease with increased platele...
Eligibility Criteria
Inclusion
- Age 6 years and above, male or female
- Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)
- Diagnosis of ITP ≥3 months, and with a platelet count of \<30 X 10\^9/L measured within 2 days prior to inclusion
- Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab or TPORAs.
- The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before the first administration
- Signed and dated written informed consent
- With normal hepatic and renal functions
- ECOG physical state score ≤ 2 points
- Cardiac function of the New York Society of Cardiac Function ≤ 2
- Patients receiving maintenance treatment (including corticosteroids (less than or equal to 0.5mg/kg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration, and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of rituximab treatment was\>3 months；More than 6 months after splenectomy.
- March 26,2024 After approval by the Ethics Committee，age of subjects has been modified to 6 years and above upon enrollment. Approval Number: IIT2023072-EC-2.
Exclusion
- Allergy to daratumumab or its excipients, or prior treatment with daratumumab that was refractory or achieved a response lasting \<6 months；
- Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases;
- HIV positive;
- Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;
- Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;
- At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;
- Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis;
- Those who have received allogeneic stem cell transplantation or organ transplantation in the past;
- Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;
- Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;
- Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);
- Patients with septicemia or other irregular severe bleeding;
- Patients taking antiplatelet drugs at the same time;
- Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.
Key Trial Info
Start Date :
December 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06168851
Start Date
December 28 2023
End Date
December 1 2030
Last Update
November 28 2025
Active Locations (1)
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1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020