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A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.

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ClinicalTrials.gov Identifier: NCT00475423
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Idiopathic Thrombocytopenic Purpura Drug: rituximab [MabThera/Rituxan] Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : May 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011


Arm Intervention/treatment
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15




Primary Outcome Measures :
  1. Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR) [ Time Frame: Week 8 ]
    Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (>) 150x10^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of >50x10^9/L over at least 2 consecutive measurements at least <2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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 than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. 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.

  12. Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event [ Time Frame: Week 52 ]
    Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.

  13. Time to Initiation of New ITP Therapy [ Time Frame: Baseline to Week 52 ]
    Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.

  14. Percentage of Therapeutic Responders [ Time Frame: Week 26 and Week 52 ]
    Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.

  15. Percentage of Participants With a Therapeutic Response [ Time Frame: Week 26 and Week 52 ]
    Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.

  16. Cluster of Differentiation 19 (CD19) B Cell Count [ Time Frame: Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day ]
    Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.

  17. Change From Baseline in CD19 B Cell Count [ Time Frame: Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day ]
    Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • refractory, relapsing or chronic idiopathic thrombocytopenic purpura;
  • stable therapy during 3 weeks prior to study entry.

Exclusion Criteria:

  • newly diagnosed ITP (<6 weeks);
  • prior treatment with MabThera;
  • active bleeding requiring platelet transfusion within 7 days prior to entry into study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475423


Locations
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Australia, New South Wales
Adelaide, New South Wales, Australia, 5011
Gosford, New South Wales, Australia, 2250
Randwick, New South Wales, Australia, NSW 2031
Sydney, New South Wales, Australia, 2139
Sydney, New South Wales, Australia, 2747
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Frankston, Victoria, Australia, 3199
Malvern, Victoria, Australia, 3144
Melbourne, Victoria, Australia, 3168
Parkville, Victoria, Australia, 3052
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00475423    
Other Study ID Numbers: ML20948
First Posted: May 21, 2007    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents