Overview
Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)
Status:
Recruiting
Recruiting
Trial end date:
2025-12-01
2025-12-01
Target enrollment:
0
0
Participant gender:
All
All
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 treatment and at least one second-line therapy including Anti-CD20 Antibody and/or TPO-RA, or those in whom no other second-line treatment options are suitable.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, ChinaTreatments:
Antibodies
Criteria
Inclusion Criteria:- Age 12-17 years old, 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 109/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.
Exclusion Criteria:
- Received any treatment of anti-CD38 antibody drug
- 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.