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

NCT01719692 | Completed DMC

• 1 other identifier: IIT2012001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

• Overall response rate at week 12

  Overall response rate was defined as proportion of subjects with a platelet count ≥ 30 × 10\^9/L and at least twice the baseline platelet count without bleeding and subjects with a platelet count ≥ 100 × 10\^9/L without bleeding at week 12 after initial administration in absence of rescue therapy, and without having had dose increment of corticosteroids during the study period.

  Patients will be followed for 6 months at least after Rituximab treatment.

Secondary Outcomes (4)

• Sustained response rate over 6 months and 1, 2, 3, 4, and 5 years after RTX initiation

  Patients will be followed for 6 months at least after Rituximab treatment.

• Time to response (TTR)

  6 months

• Number of subjects with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale

  3 months

• Adverse events assessment

  12 months

Study Arms (2)

Rituximab A group

EXPERIMENTAL

375mg/m2 for once

Drug: Rituximab

Rituximab B group

ACTIVE COMPARATOR

100mg/week for four weeks

Drug: Rituximab

Interventions

Rituximab DRUG

Also known as: Trade names Rituxan and MabThera

Rituximab A group; Rituximab B group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years old;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Langfang Traditional Chinese Medicine Hospital: collaborator
• Henan Cancer Hospital: collaborator
• The Second Affiliated Hospital of Kunming Medical University: collaborator
• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Hospital of Blood disease

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Rituximab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• RENCHI YANG, Dr

  Hospital of Blood disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: November 1, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 11, 2026

Record last verified: 2024-03

Locations

CN (1)