Clinical Trial: A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia
Brief Summary: The aim of this prospective study was to evaluate the activity, safety and the duration of the response of low dose rituximab associated with standard oral prednisone as first line therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease, and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral prednisone. Further aim was to correlate the clinical response to biological parameters (cytokine and anti-erythrocyte antibody production in cultures).
Detailed Summary:
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Current Primary Outcome: overall response [ Time Frame: month +2 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Sustained response (SR) [ Time Frame: month +6, month +12 ]
Original Secondary Outcome: Same as current
Information By: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Dates:
Date Received: April 28, 2011
Date Started: January 2009
Date Completion:
Last Updated: April 29, 2011
Last Verified: April 2011