NCT06168851 Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)
| NCT ID | NCT06168851 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-12-28 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-12-28 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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: * 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.
Contact & Investigator
Lei Zhang, MD
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Science and Blood Disease Hospital
Frequently Asked Questions
Who can join the NCT06168851 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Immune Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06168851 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06168851 currently recruiting?
Yes, NCT06168851 is actively recruiting participants. Contact the research team at sunting@ihcams.ac.cn for enrollment information.
Where is the NCT06168851 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06168851 clinical trial?
NCT06168851 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Lei Zhang, MD at Chinese Academy of Medical Science and Blood Disease Hospital. The trial plans to enroll 60 participants.