Clinical Trial: A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura.
Brief Summary: This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP). Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR) [ Time Frame: Week 8 ]
Original Primary Outcome: Overall response rate at week 8.
Current Secondary Outcome:
- Percentage of Participants With Hematological CR, PR, or Minor Response (MR) [ Time Frame: Week 8 ]Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10^9/L, PR ≥ 50x10^9/L, MR equals (=) 30x10^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy.
- Percentage of Participants Who Achieved CR [ Time Frame: Week 52 ]CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
- Time to CR [ Time Frame: Baseline to Week 52 ]Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment.
- Percentage of Participants Who Achieved PR [ Time Frame: Week 52 ]PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
- Time to PR [ Time Frame: Baseline to Week 52 ]Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts > 50x10^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
- Percentage of Participants Who Achieved MR [ Time Frame: Week 52 ]MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
- Time to MR [ Time Frame: Baseline to Week 52 ]Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
- Percentage of Participants With Continued CR From Week 8 to Week 52 [ Time Frame: Week 8 to Week 52 ]The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
- Duration of CR in Participants With Continued CR From Week 8 Until Week 52 [ Time Frame: Week 8 to Week 52 ]Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
- Duration of PR in Participants With Continued PR From Week 8 Until Week 52 [ Time Frame: Week 8 to Week 52 ]Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
- Duration of MR in Participants With Continued MR From Week 8 Until Week 52 [ Time Frame: Week 8 to Week 52 ]Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of > 30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more th
Original Secondary Outcome: Efficacy: Time to complete and partial response; complete and partial response rates; duration of response; time to new therapy. Safety: AEs, hematological toxicity, infections, infusion reactions.
Information By: Hoffmann-La Roche
Dates:
Date Received: May 17, 2007
Date Started: May 2007
Date Completion:
Last Updated: February 4, 2015
Last Verified: February 2015
