Clinical Trial: Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura (ITP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double Blind, Placebo Controlled Pilot Trial of Rituximab for Non-splenectomized Adults With Acute Immune Thrombocytopenic Purpura Receiving Standard Treatme

Brief Summary: The purpose of this study is to assess the feasibility of a randomized, double blind, placebo controlled trial of add-on rituximab for non-splenectomized adults with acute immune thrombocytopenic purpura (ITP).

Detailed Summary:

Immune thrombocytopenic purpura (ITP) is an autoimmune disease characterized by severe thrombocytopenia and bleeding. With current standard therapies, adult-onset ITP tends to recur thus exposing patients to prolonged risks of hemorrhage and toxicities of standard treatments. Rituximab, a chimeric anti-CD20 monoclonal antibody, has been shown to be effectively raise the platelet count in some patients with ITP and there is clinical and biological evidence to suggest that, if given early, rituximab may prevent ITP relapses.

We have designed a randomized, double blind, placebo controlled pilot trial of rituximab for the treatment of non-splenectomized adults with acute ITP who are receiving standard treatments. The primary objectives of this trial are to determine the feasibility of recruitment, randomization and blinding; the safety of rituximab in ITP; and the event rate in the control group which will be used to calculate the sample size for a larger trial. Secondary objectives are to determine rates of 6-month event free survival where an event is defined as any of: a platelet count <50; the need for rescue treatment; or significant bleeding. Data from this pilot trial will inform the design of a larger phase III trial.


Sponsor: Hamilton Health Sciences Corporation

Current Primary Outcome:

  • Feasibility of recruitment [ Time Frame: 3 years ]
  • Degree of adherence to the study protocol [ Time Frame: 3 years ]
  • Event free survival in controls [ Time Frame: 6 months ]
  • Bleeding [ Time Frame: 6 months ]
  • rescue therapy [ Time Frame: 6 months ]


Original Primary Outcome:

  • Feasibility of recruitment
  • Degree of adherence to the study protocol
  • 6-month event free survival in controls
  • Safety


Current Secondary Outcome:

  • Platelet count response [ Time Frame: 6 months ]
  • Quality of life [ Time Frame: 6 months ]
  • Circulating CD-20 positive lymphocytes [ Time Frame: 6 months ]
  • Platelet associated IgG [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Platelet count response
  • Quality of life
  • Circulating CD-20 positive lymphocytes
  • Platelet associated IgG


Information By: McMaster University

Dates:
Date Received: September 6, 2006
Date Started: September 2006
Date Completion:
Last Updated: June 6, 2012
Last Verified: June 2012