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Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)

A Randomized, Open-label Study To Compare The Efficacy And Safety Of Daratumumab Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy

NCT07362238•Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with Rituximab in pediatric ITP patients.This study will be conducted in pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.

Detailed Description

Pediatric Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized by decreased platelet count and skin and mucosal bleeding. Pediatric ITP is a kind of disease with increased platelet destruction and impaired platelet production caused by autoimmunity. Conventional treatment of pediatric ITP includes first-line glucocorticoid and immunoglobulin therapy, second line TPO and TPO receptor agonist, splenectomy and other immunosuppressive treatments (such as rituximab, vincristine, azathioprine, etc.). ITP is one of the most common hemorrhagic diseases. At present, the treatment response of ITP is not good, and a considerable number of patients need drug maintenance treatment, which seriously affects the quality of life of patients and increases the economic burden of patients. Therefore, there is still a lack of effective treatment for pediatric ITP, especially for recurrent and refractory ITP patients, which is one of the problems that have attracted more attention and need to be solved urgently. The main pathogenesis of ITP is the loss of platelet autoantigen immune tolerance, which leads to abnormal activation of humoral and cellular immunity. It is characterized by antibody mediated platelet destruction and insufficient platelet production by megakaryocytes. The residual long-term autoreactive plasma cells may be a source of therapeutic resistance to autoimmune cytopenia. Antiplatelet specific plasma cells have been detected in the spleen of patients with rituximab refractory ITP. Therefore, the strategy of simply eliminating B cells may not work, because LLPC will continue to produce pathogenic antibodies. In view of this, anti-CD38 monoclonal antibody can eliminate LLPC, thereby profoundly reducing the production of pathogenic antibodies and achieving good efficacy. Some pediatric patients in our center have been treated with this Daratumumab (anti-CD38 monoclonal antibody) in the past, with good efficacy and safety. Therefore, we planned to conduct a clinical study to evaluate the safety and efficacy of Daratumumab (anti-CD38 monoclonal antibody) versus rituximab in relapsed pediatric patients with primary immune thrombocytopenia, in order to provide more treatment options for pediatric patients with ITP.

Eligibility

Age

6 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥6，\<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 were required to have a response history (PLT≥50×10\^9/L) to standard first-line treatment of ITP (glucocorticoid and/or intravenous immunoglobulin).
•Subjects with a platelet count of \<30×10\^9/L within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) \<30×10\^9/L during the screening visit, and no platelet count \> 35×10\^9/L.
•ECOG performance status score of ≤2.
•Enrollment of subjects receiving maintenance therapy with a stable dosage is permitted, including glucocorticoids (≤0.5 mg/kg of prednisone or equivalent) or TPO receptor agonists. However, at the time of enrollment, subjects are restricted to using only one concomitant medication with a stable dose, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug.
•Subjects and the legal guardian comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.

Exclusion Criteria

•Subjects with a history of using CD20 monoclonal antibody or CD38 monoclonal antibody.
•Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.
•Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.
•Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.
•Subjects who have used anticoagulants or any agents with antiplatelet effects, such as aspirin, within 3 weeks prior to the first dose of study drug.
•Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.
•Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have receive medications including cyclophosphamide and vindesine within 6 months prior to the first dose of study drug.
•Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.
•Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.
•Subjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).
+15 more criteria

Locations (1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, China

Key Dates

Start Date

March 1, 2026

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2028

Last Updated

January 23, 2026

Enrollment

122

ESTIMATED participants

Conditions

Immune ThrombocytopeniaTreatment

Interventions

Rituximab

DRUG

Daratumumab

DRUG

Contacts

Lei Zhang, MD

CONTACT

+8613502118379 zhanglei1@ihcams.ac.cn

Ting Sun, MD

CONTACT

+8615822339131 sunting@ihcams.ac.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)

Inclusion Criteria

Exclusion Criteria

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