A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Children With Primary Immune Thrombocytopenia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of primary immune thrombocytopenia in patients who have failed first-line treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
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• Age ≥6 years, ≤18 years, male or female.

• Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.

• Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Patients should have a history of response to previous ITP standard first-line therapy (glucocorticoids and/or intravenous human immunoglobulin) (PLT≥50×10\^9/L);

• Platelet count \<30×10\^9/L within 24 hours before the first administration of the study drug; During the screening period, platelet counts were measured at least 2 times (at least 1 week apart), with an average platelet count \<30×10\^9/L and no platelet count \> 35×10\^9/L.

• ECOG performance status score of ≤2.

• Enrollment of subjects receiving maintenance therapy is permitted, including glucocorticoids (≤0.5 mg/kg of prednisone or equivalent) or TPO receptor agonists. Only one concomitant medication was allowed at the time of enrollment, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the first dose of the study drug.

• For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4/6 months after the cessation of study drug treatment.

• Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.

Locations
Other Locations
China
Chinese Academy of Medical Science and Blood Disease Hospital
RECRUITING
Tianjin
Contact Information
Primary
Ting Sun, MD
sunting@ihcams.ac.cn
+8615822339131
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-08
Participants
Target number of participants: 30
Treatments
Experimental: Intervention (Daratumumab)
30 enrolled subjects: once a week x 4 doses
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov