Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Dec 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Anti-CD38 Antibody for children and teenagers aged 12 to 17 who have a condition known as Immune Thrombocytopenia (ITP). ITP is a disorder where the body does not have enough platelets, which are important for blood clotting. This trial is specifically for patients who haven’t had good results from previous treatments or have had a relapse after trying other therapies. Participants must have been diagnosed with ITP for at least three months and have low platelet counts.

Eligible participants will be those who have tried treatments like steroids and other medications but still have not found relief. Before joining the study, they need to be in stable health, with no severe underlying conditions, and should have stopped certain treatments for a specified time. If chosen to participate, patients can expect to receive the Anti-CD38 Antibody and will be monitored closely for safety and effectiveness. It’s important to know that this trial is currently recruiting participants, and families will need to provide consent for their child to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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.