Clinical Trial: Rituximab in Auto-Immune Hemolytic Anemia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional




Official Title: Rituximab in Adult's Warm Auto-Immune Hemolytic Anemia : a Phase III, Double-bind, Randomised Placebo-controlled Trial

Brief Summary: The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patients (17 in each arm) will be include (amendment n°6 - 15/10/2013) over a 3 year period (amendment n°3 - 11/12/2012).

Detailed Summary:

The primary aim of the study is to assess the efficacy (overall response rate at 1 year) of rituximab (an anti-CD20 monoclonal antibody) in AIHA due to warm autoantibody when administered at the initial phase of the disease. All eligible patents with a newly diagnosed AIHA (within 6 weeks after diagnosis) will be treated by corticosteroids at standard dose (prednisone 1 mg/kg/day) and will be randomized into 2 arms: Rituximab or placebo 1000 mg on days 1 and 15 in a 1/1 ratio. As soon as at least a partial remission (PR) of AIHA will be achieved, the daily dose of prednisone will be tapered following the rules provided by the protocol.

The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty two patients (16 in each arm) will be include over a 2 year period.


Sponsor: Assistance Publique - Hôpitaux de Paris




Current Primary Outcome: Overall response rate (complete and partial response) in both arms [ Time Frame: at 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Comparison in both arms of the mean cumulative doses of prednisone [ Time Frame: at 1 year ]
  • Comparison in both arms of the number of transfusions of packed red blood cells in both arms [ Time Frame: at 1 year ]
  • Comparison in both arms of the number of days in hospital [ Time Frame: within the first year of follow-up ]
  • Comparison in both arms of the number of patients requiring a splenectomy and/or an immunosuppressor [ Time Frame: during the first 12 months of follow-up ]
  • Comparison in both arm of the mortality [ Time Frame: at 1 year ]
  • Comparison in both arm of overall response (CR + PR) [ Time Frame: at 2 years ]
  • Comparison of the incidence of serious side effects in both arms [ Time Frame: at 1 year ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris




Dates:
Date Received: August 12, 2010
Date Started: March 2011
Date Completion: July 2016
Last Updated: October 18, 2015
Last Verified: October 2015