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Efficacy and Safety Assessment of a Treatment Combining Rituximab and Belimumab in Adults With Persistent Immune Thrombocytopenia — RITUX PLUS  

Immune Thrombocytopenia Clinical Trial

Official title:
RITUX-PLUS. A Prospective Open Trial to Assess the Efficacy and Safety of a Treatment Combining Rituximab and Belimumab in Adults With Persistent Immune Thrombocytopenia.

Clinical Trial Summary

Previous studies have shown that increase level of BAFF could promote the settlement of long-lived plasma cells in the spleen of ITP patients treated with anti-CD20. This single-center prospective pilot study, currently in phase IIa, will evaluate the efficacy of a rituximab and belimumab sequential combination treatment. Investigators plan to include 15 patients with persistent ITP over a 24-month inclusion period. Each patient will be followed for 1 year

Clinical Trial Description

This single-center prospective pilot study, currently in phase IIa, evaluates the efficacy of a rituximab and belimumab sequential combination treatment. Based on the Fleming method, this study scheme includes a single step method.

Eligible patients, having given consent and having been verified for inclusion criteria, will receive two intravenous perfusions of 1 g of Rituximab (Mabthera ®) at W0 and W2 coupled with 100 mg intravenous methylprednisone to avoid potential allergic reactions.

Five belimumab (Benlysta ®) injections will be administered (W0 + 2days, W2 + 2 days, W4, W8, W12) at 10mg/kg doses. The first two injections are administered 2 days after Rituximab perfusions. The adopted experimental scheme was once used to show use of belimumab in systemic lupus erythematosus in accordance with AMM regulation.

This phase II prospective single-center open-trial will be conducted at the National Referral Center for Adult Immune Cytopenia located in the Henri Mondor University Hospital. Investigators plan to include 15 patients with persistent ITP over an 24-month inclusion period. Each patient will be followed for 1 year ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03154385
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase N/A
Start date March 13, 2017
Completion date November 13, 2019
View Details
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