Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-17
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Anti-CD38 antibody Injection
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Beijing Children's Hospital
Collaborator
Tianjin Children's Hospital
Collaborator
Source ClinicalTrials.gov