Using Obinutuzumab to treat immune thrombocytopenia

A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-Human CD20 Monoclonal Antibody Obinutuzumab in the Treatment of Primary Immune Thrombocytopenia

This study tests if Obinutuzumab can help adults with immune thrombocytopenia who haven't had enough success with other treatments to improve their platelet counts.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: rituximab, prednisone, Obinutuzumab
• Locations: 1 site (Tianjin)
• Trial ID: NCT05995054 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Obinutuzumab, a monoclonal antibody, in treating patients with immune thrombocytopenia (ITP) who have not responded adequately to first-line treatments. The study focuses on adult patients diagnosed with ITP for at least three months and experiencing low platelet counts. Participants will receive Obinutuzumab injections and will be monitored for treatment response and safety outcomes. The trial aims to address the urgent need for effective therapies in recurrent and refractory ITP cases.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of immune thrombocytopenia and low platelet counts who have failed previous treatments.

Not a fit: Patients who have not been diagnosed with immune thrombocytopenia or those who have not experienced treatment failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from immune thrombocytopenia, improving their quality of life.

How similar studies have performed: While the use of Obinutuzumab in ITP is a novel approach, similar monoclonal antibody treatments have shown promise in other autoimmune conditions.

Eligibility criteria

Inclusion Criteria:

* Age 18 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 109/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 109/L）
* Failure to achieve response or relapse after corticosteroid therapy
* 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.

Exclusion Criteria:

* 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;
* Subjects with extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage;
* Subjects with heart disease that requires treatment or hypertension that has been judged by researchers to be poorly controlled currently;
* Subjects with any venous or arterial thrombosis, atherosclerosis, and other diseases;
* Subjects with a history of malignant solid tumor or have received allogeneic stem cell transplantation or organ transplantation;
* Subjects with mental disorders who are unable to sign normal informed consent and conduct trials and follow-up;
* Subjects whose toxic symptoms caused by pre-trial treatment have not disappeared;
* Subjects with other serious diseases that may limit their participation in this trial (diabetes; severe cardiac insufficiency; myocardial obstruction or unstable arrhythmia or unstable angina pectoris in the last 6 months; gastric ulcer; active autoimmune disease, etc.);
* Subjects with septicemia or other irregular bleeding;
* Female subjects who are nursing or pregnant/suspected pregnant (positive pregnancy tests for human chorionic gonadotropin in urine during screening).
* Patients taking antiplatelet drugs at the same time;

Where this trial is running

Tianjin

• Chinese Academy of Medical Science and Blood Disease Hospital — Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Lei Zhang, MD — Chinese Academy of Medical Science and Blood Disease Hospital
• Study coordinator: Yunfei Chen, MD

Conditions Immune Thrombocytopenia; Treatment