Clinical Trial: Rituximab in Patients With Relapsed or Refractory TTP-HUS

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase II Study Evaluating the Efficacy of Rituximab in the Management of Patients With Relapsed/Refractory Thrombotic Thrombocytopenic Purpura (TTP) - Hemolytic Uremic S

Brief Summary: The general objective of this study is to assess the efficacy and safety of Rituximab in the management of patients with refractory or relapsed thrombotic thrombocytopenic purpura-hemolytic uremic syndrome (TTP-HUS). There have been several case reports and case series describing the use of Rituximab in patients with TTP-HUS; however its use has not been studied in a large trial. It is hypothesized that Rituximab may ameliorate the severity of certain cases of TTP-HUS by decreasing the number of activity of B-cells which may result in decreased production of the ADAMTS13 protease inhibitor. Patients with TTP-HUS not responding to standard therapy or patients with relapsed disease may have particular benefit. Treatments that decrease the frequency of relapse or shorten the time to remission of TTP-HUS will be of benefit by decreasing the need for blood product support.

Detailed Summary:
Sponsor: Hamilton Health Sciences Corporation

Current Primary Outcome: The proportion of patients achieving all: (1) platelet count >150x109/L; (2) LDH < 1.5 x normal; (3) no requirement for plasma exchange therapy; (4) asymptomatic. [ Time Frame: 8 weeks after initiation of therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • proportion of patients with platelet count greater than 150 x 109/L [ Time Frame: 8 weeks ]
  • proportion of patients with LDH < 1.5 X normal [ Time Frame: 8 weeks ]
  • proportion of patients with no requirement for plasma exchange therapy [ Time Frame: 8 weeks ]
  • proportion of patients who are asymptomatic (no new neurological symptoms ans stabilization of previous neurological symptoms [ Time Frame: 8 weeks ]
  • clinical response (CR, PR, non-response) [ Time Frame: 52 weeks ]
  • frequency of relapse [ Time Frame: 52 weeks ]
  • mortality [ Time Frame: 52 weeks ]
  • changes from baseline in platelet counts, LDH, ADAMTS13 protease level, ADAMTS13 inhibitor level [ Time Frame: 8, 12, 24, 52 weeks ]
  • toxicity and clinical safety as assessed by monitoring of adverse events, laboratory parameters, vital signs during infusion, and immediate tolerability [ Time Frame: 8 weeks ]


Original Secondary Outcome: Same as current

Information By: McMaster University

Dates:
Date Received: September 17, 2007
Date Started: December 2007
Date Completion: January 2011
Last Updated: May 18, 2010
Last Verified: September 2007