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.
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
Subjects with primary disease of important organs (liver, kidney, heart, etc.), or with immune system diseases;
Secondary thrombocytopenia caused by various reasons, such as connective tissue disorders, bone marrow hematopoietic failure disease, myelodysplastic syndrome, malignancy, drugs, inherited thrombocytopenia, common variable immune deficiency, lymphoma, etc.;
Subjects infected with human immunodeficiency virus (HIV);
Uncontrollable or active infections during the screening period, including hepatitis B, hepatitis C, cytomegalovirus, EB virus, or positive syphilis antigen;
Single group
Obinutuzumab Injection [Gazyva]
Drugintravenous Obinutuzumab administration This study adopts a prospective, single arm, open design method. 60 subjects were enrolled in the study and were treated with CD20 monoclonal antibody (Obinutuzumab: 1000mg) for once. The first stage is the main research stage (d1-w12), which is the core treatment period. The subjects will receive intravenous infusion of 1000mg Obinutuzumab for once to observe the safety and efficacy during treatment. The second stage (w12-w48) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Obinutuzumab after treatment.
Evaluation of overall efficacy response after Obinutuzumab treatment within 12 weeks
Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10\^9/L and at least 2-fold from baseline at the meanwhile within 12 weeks after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
Evaluation of overall efficacy response after Obinutuzumab treatment within 8 weeks
Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10\^9/L and at least 2-fold from baseline at the meanwhile within 8 weeks after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
Evaluation of overall efficacy response after Obinutuzumab treatment within 6 months
Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10\^9/L and at least 2-fold from baseline at the meanwhile within 6 months after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
Evaluation of overall efficacy response after Obinutuzumab treatment within 12 months
Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10\^9/L and at least 2-fold from baseline at the meanwhile within 12 months after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
Evaluation of sustained response rate after Obinutuzumab treatment within 6 months
Sustained response rate defined as proportion of subjects who keep a platelet count ≥ 30 × 10\^9/L and at least 2-fold from baseline at the meanwhile at 6 months after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
Prognostic model establishment using multi-omics data such as transcriptome, proteome, metabolome, microbiome, et al.
The prognosis related factors will be selected from multi-omics data such as transcriptome, proteome, metabolome, microbiome, et al. And then selected prognosis related factors will be used to establish prognosis prediction model
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