Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia

NCT ID: NCT01719692

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-02-29

Brief Summary

A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this study is to compare the efficacy and tolerability of two different regimens of low doses rituximab for the treatment of adult patients with ITP.

Detailed Description

This is a multicentre, prospective, open-label, randomised controlled trial. The aim of this study will compare the long-term efficacy and safety of two low-dose rituximab regimens in adult Chinese patients with glucocorticoid-resistant/dependent or relapsed ITP. Group A will receive rituximab100 mg weekly for four weeks, and group B will receive rituximab 375 mg/m2 once. After initiating treatment, if the patient has at least two consecutive evaluations (interval >7 days) without rescue therapy and a platelet count >50×109/L, the concomitant medications such as glucocorticoids can be reduced or stopped.

Within 3 months of the last rituximab dose, rescue therapy is recommended if the patient has an extremely low platelet count and an obvious bleeding tendency. Rescue therapy is limited to IVIG (0.4 g/kg per day for 3-5 days) and glucocorticoid (methylprednisolone 0.8 mg/kg per day for 7-14 days or equivalent dose of other glucocorticoids).

Conditions

Immune Thrombocytopenic Purpura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab A group

375mg/m2 for once

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

Rituximab B group

100mg/week for four weeks

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: DRUG

Interventions

Rituximab

Intervention Type: DRUG

Other Intervention Names

Trade names Rituxan and MabThera

Eligibility Criteria

Inclusion Criteria

• Age 18-60 years old;
• Diagnosis of primary immune thrombocytopenia according to the guidelines of American Society of Hematology for at least 3 months before inclusion;
• Platelet count <30×109/L (measured at least twice during the screening, with at least a 1-week interval);
• Failed or dependent on or relapsed after previous treatment with glucocorticoid;
• If on glucocorticoid maintenance therapy, dose ≤0.5 mg/kg prednisone or equivalent and stabilised for at least 4 weeks;
• Drugs such as azathioprine, danazol, cyclosporine A, tacrolimus, and sirolimus stopped for at least 4 weeks;
• Splenectomy more than 6 months previously;
• Previous rescue therapy of ITP (including methylprednisolone, platelet transfusion and IVIG) completed at least 2 weeks before the first administration;
• Liver and kidney function (including alanine aminotransferase, aspartate aminotransferase, total bilirubin, serum creatine, urea nitrogen, etc.) less than 1.5 times the upper limit of normal value;
• Eastern Cooperative Oncology Group performance status ≤2;
• Cardiac function classification (New York Heart Association) ≤2;
• Understand the research procedure and voluntarily sign a written informed consent form.

Exclusion Criteria

• Patients with secondary thrombocytopenia (including myelodysplastic syndrome, aplastic anemia, common variant immunodeficiency disease, hereditary thrombocytopenia, drug-induced thrombocytopenia, pseudothrombocytopenia, connective tissue disease secondary thrombocytopenia, thrombocytopenia after liver disease, etc.);
• Previous treatment of RTX or allergic to RTX;
• Uncontrollable primary diseases of important organs (including malignant tumor, liver failure, heart failure, kidney failure and other diseases);
• HIV-positive status;
• Active infection including hepatitis B (HBV), hepatitis C (HCV) and other viral antigens or DNA, RNA positive; cytomegalovirus, Epstein-Barr virus, syphilis chronic or active infection. If HBV core antibodies are positive, HBV-DNA testing is required.
• Extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.
• Heart disease or arrhythmia need treatment, or poorly controlled hypertension;
• Thrombotic diseases including pulmonary embolism, thrombosis, atherosclerosis, etc.;
• Previously allogeneic stem cell transplantation or organ transplantation;
• Mental disorders who are unable to obtain informed consent normally and participate in trials and follow-up;
• Symptoms of toxicity from pre-trial treatment have not resolved;
• Other severe conditions that may limit participation in the trial (e.g., diabetes; severe cardiac insufficiency; myocardial infarction or unstable arrhythmia or unstable angina within the last 6 months; gastric ulcer; active autoimmune diseases, etc.);
• Sepsis or other irregular bleeding;
• Taking antiplatelet drugs;
• pregnancy, suspected pregnancy (urine human chorionic gonadotropin positive during screening) or lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Langfang Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

RENCHI YANG, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital of Blood disease

Locations

Hospital of Blood disease

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

IIT2012001

Identifier Type: -

Identifier Source: org_study_id