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  ICMJEMay 2008
Estimated Primary Completion DateJune 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 ICMJESame as current
Change HistoryComplete 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 ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy 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
Official Title  ICMJEA 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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment
Condition  ICMJEMantle Cell Lymphoma
Intervention  ICMJE
  • Drug: Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
    Rituximab intravenous on Day 1, Cyclophosphamide intravenous on Day 1, Doxorubicin intravenous on Day 1, VELCADE intravenous on Days 1,4,8, and 11, Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
    Other Name: VcR-CAP
  • Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
    Rituximab intravenous on Day 1, Cyclophosphamide intravenous on Day 1, Doxorubicin intravenous on Day 1, Vincristine intravenous on Day 1, Prednisone by mouth on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
    Other Name: R-CHOP
Study Arms / Comparison Groups
  • VcR-CAP: Experimental
    Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
    Intervention: Drug: Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
  • R-CHOP: Active Comparator
    Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
    Intervention: Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

Recruitment Information

Estimated Enrollment  ICMJE486
Estimated Completion DateJuly 2012
Estimated Primary Completion DateJune 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients 18 years or older.
  • Diagnosis of mantle cell lymphoma (Stage II, III or IV).
  • At least 1 measurable site of disease.
  • No prior therapies for mantle cell lymphoma.
  • Not eligible for bone marrow transplantation.

Exclusion Criteria:

  • Prior treatment with VELCADE.
  • Prior anti-neoplastic (including unconjugated therapeutic antibodies), experimental or radiation therapy, radioimmunoconjugates or toxin immunoconjugates for the treatment of mantle cell lymphoma.
  • Major surgery.
  • Active systemic infection requiring treatment and patients with known diagnosis of HIV or active Hepatitis B.
  • Peripheral neuropathy or neuropathic pain of Grade 2 or worse.
  • Diagnosed or treated for a malignancy other than mantle cell lymphoma (MCL) within 1 year of randomization, or who were previously diagnosed with a malignancy other than MCL and have any radiographic or biochemical marker evidence of malignancy.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center1-866-835-2233medical@mlnm.com
Location Countries  ICMJEUnited 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  ICMJENCT00722137
Responsible PartyClinical Research Monitor, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID Numbers  ICMJE26866138-LYM-3002
Study Sponsor  ICMJEMillennium Pharmaceuticals, Inc.
Collaborators  ICMJEJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators  ICMJE
Study Director:Medical MonitorMillennium Pharmaceuticals, Inc.
Information Provided ByMillennium Pharmaceuticals, Inc.