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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00722137
First received: July 23, 2008
Last updated: December 10, 2013
Last verified: December 2013

July 23, 2008
December 10, 2013
May 2008
June 2012   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 18-25 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00722137 on ClinicalTrials.gov Archive Site
Overall response rate [ Time Frame: 18-25 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Mantle Cell Lymphoma
  • Drug: Rituximab
    Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
  • Drug: Cyclophosphamide
    Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
  • Drug: Doxorubicin
    Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
  • Drug: VELCADE
    VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
  • Drug: Prednisone
    Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
  • Drug: Vincristine
    Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
  • Experimental: VcR-CAP
    Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
    Interventions:
    • Drug: Rituximab
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: VELCADE
    • Drug: Prednisone
  • Active Comparator: R-CHOP
    Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
    Interventions:
    • Drug: Rituximab
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: Prednisone
    • Drug: Vincristine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
486
January 2014
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT00722137
26866138-LYM-3002
Not Provided
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP