Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP

Peking University

Status and phase: Not yet enrolling; Phase 2

Conditions: Immune Thrombocytopenia (ITP)

Treatments: Drug: low-dose rituximab; Drug: Iguratimod

Study type: Interventional

Funder types: Other

Identifiers

NCT07057778

Pku-IGU-ITP-03

Details and patient eligibility

About

Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.

Full description

Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of steroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Rituximab has been shown to partly improve the complete remission rate of ITP. The small molecule compound iguratimod is widely used as a novel antirheumatic drug to treat several autoimmune diseases. According to studies involving ITP mice, iguratimod may represent a new approach for the prevention and treatment of anti-platelet antibody-mediated ITP by modulating T-cell differentiation.

A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to the low-dose rituximab+iguratimod and the low-dose rituximab monotherapy groups. Platelet count, bleeding and other symptoms were evaluated before and after treatment.Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and iguratimod in patients with steroid-resistant/relapsed ITP.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ITP confirmed by excluding other supervened causes of thrombocytopenia;
• Platelet count of less than 30×10^9/L at enrollment;
• Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;

Exclusion criteria

• Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus);
• Congestive heart failure;
• Severe arrhythmia;
• Nursing or pregnant women;
• Aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria;
• Creatinine or serum bilirubin levels each 1•5 times or more than the normal range;
• Active or previous malignancy;
• Patients with other diseases were undergoing treatment with immunosuppressants;
• Patients with ITP had received rituximab;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Iguratimod plus low-dose rituximab

Experimental group

Description:

Low-dose rituximab was used in combination with Iguratimod

Treatment:

Drug: Iguratimod

Drug: low-dose rituximab

Low-dose rituximab

Active Comparator group

Description:

Low-dose rituximab alone

Treatment:

Drug: low-dose rituximab