Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma
Tracking Information
Start Date ICMJE | May 2008 |
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Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: July 23, 2008) | Progression free survival [ Time Frame: 18-25 months ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00722137 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 23, 2008) | Overall response rate [ Time Frame: 18-25 months ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma |
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Official Title ICMJE | A Randomized, Open-Label, Multicentre Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma Who Are Not Eligible for a Bone Marrow Transplant |
Brief Summary | This is a randomized, open-label, multicentre, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in patients who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment |
Condition ICMJE | Mantle Cell Lymphoma |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 486 | ||||
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Estimated Completion Date | July 2012 | ||||
Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Germany, Hungary, India, Israel, Italy, Malaysia, Morocco, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Tunisia, Turkey, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00722137 | ||||
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Responsible Party | Clinical Research Monitor, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
Study ID Numbers ICMJE | 26866138-LYM-3002 | ||||
Study Sponsor ICMJE | Millennium Pharmaceuticals, Inc. | ||||
Collaborators ICMJE | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
Investigators ICMJE |
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Information Provided By | Millennium Pharmaceuticals, Inc. |
Source: http://clinicaltrials.gov/