The Combination of Low-dose Rituximab and ATRA as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

• Status: Active, not recruiting
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborators: Beijing Hospital; Beijing Tongren Hospital; Navy General Hospital, Beijing
• Treatments: Rituximab; Tretinoin

Criteria

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;

• ECOG<2.

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