A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-Human CD20 Monoclonal Antibody Obinutuzumab in the Treatment of Pediatric 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 Obinutuzumab in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line glucocorticoid treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
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• Age 12-18 years old, male or female

• Conform to the diagnostic criteria of persistent or chronic immune Thrombocytopenia (ITP)

• With a platelet count of \<30 X 10\^9/L measured within 2 days prior to administration(Platelet counts were measured at least 2 times during screening (at least 1 week apart) with platelets\<30 X 10\^9/L)

• Failure or recurrence of previous hormonal therapy or hormone dependence

• 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 Liver and kidney function\<1.5×upper limit of normal, such as ALT、AST,BUN,Cre,etc.

• 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.

Locations
Other Locations
China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITING
Tianjin
Contact Information
Primary
Ting Sun, MD
sunting@ihcams.ac.cn
+8615822339131
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-11
Participants
Target number of participants: 60
Treatments
Experimental: Intervention (Obinutuzumab)
60 enrolled subjects: one infusion
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov