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 ]

Response will be evaluated at each clinic visit. Complete response (CR) will be defined as Hb increase >2 g/dL and Hb > 12 g/dL, normalization of all haemolytic markers and no transfusion requirement;Partial response (PR) will be defined as Hb increase >2 g/dL and Hb 10-12 g/dL, and 50% reduction of transfusion. In the remaining cases there is no response.


Original Primary Outcome: Same as current

Current Secondary Outcome: Sustained response (SR) [ Time Frame: month +6, month +12 ]

Sustained response (SR) was defined as Hb > 10 g/dL at month +6 and +12, in the absence of any treatment.


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