A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Immune Thrombocytopenia

NCT05995054 | Recruiting Phase 2 DMC

• 1 other identifier: IIT2023039
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of Obinutuzumab in the treatment of immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment.

Conditions

Immune Thrombocytopenia; Treatment

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (12)

• Evaluation of overall efficacy response after Obinutuzumab treatment within 8 weeks

  8 weeks

• Evaluation of overall efficacy response after Obinutuzumab treatment within 6 months

  6 months

• Evaluation of overall efficacy response after Obinutuzumab treatment within 12 months

  12 months

• Evaluation of sustained response rate after Obinutuzumab treatment within 6 months

  6 months

• Evaluation of sustained response rate after Obinutuzumab treatment within 12 months

  12 months

Study Arms (1)

Intervention (Obinutuzumab)

EXPERIMENTAL

110 enrolled subjects: one infusion

Drug: Obinutuzumab Injection [Gazyva]

Interventions

Obinutuzumab Injection [Gazyva] DRUG

intravenous Obinutuzumab administration This study adopts a prospective, single arm, open design method. 110 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.

Intervention (Obinutuzumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, 300020, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

obinutuzumab

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Lei Zhang, MD

  Chinese Academy of Medical Science and Blood Disease Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunfei Chen, MD

CONTACT

+8618502220788; chenyunfei@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: August 28, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months to 36 months after study completion
• Access Criteria: Upon request to PI

Locations

CN (1)