Adult Immune Thrombocytopenia (ITP) Clinical Trial
Official title:
Prospective Multicenter Randomized Open-label Controlled Trial Assessing Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia
Due to its expected efficacy based on the retrospective data available in ITP, its relatively
good safety profile and its very low cost , dapsone could be a good steroid-sparing
second-line option for adults with ITP.
This study is a phase III prospective multicenter randomized open trial comparing two
treatment strategies:
- Arm A (experimental arm): prednisone at 1 mg/kg for 3 weeks + dapsone at 100 mg per day
up to week 52 if an initial response is achieved.
- Arm B (control arm): prednisone alone at 1 mg/kg for 3 weeks followed by monitoring and
"standard of care" The aim of the study is to demonstrate the efficacy of dapsone based
on the overall response rate (including response and complete response) as a second-line
treatment for adults with newly-diagnosed persistent or chronic (modified by amendment
08/11/2016) ITP not achieving a durable response with corticosteroids. The primary
endpoint will be the overall response-rate (response or complete response according to
standard definitions) in both arms at week 52 (1 year).
The secondary endpoints are the following :
- To assess the safety of dapsone over the study period and especially the incidence of
cutaneous reactions.
- To analyze the overall response rate (platelet count > 30 x 109/L with at least a
doubling of the pre-treatment count in the absence of any other ITP treatment) in both
treatment arms at week 24.
- To compare the rate of complete response and failure in both arms at 24 and 52 weeks.
- To compare time to treatment failure (TTF) in both arms
- To investigate the mechanisms of action of dapsone in ITP in a subgroup of patients
(ancillary study)
n/a