Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Sponsor
Millennium Pharmaceuticals, Inc.
Study ID
NCT01040871
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VELCADE — DRUG
    VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles.
  • Rituximab — DRUG
    Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
  • Cyclophosphamide — DRUG
    Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
  • Doxorubicin — DRUG
    Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
  • Prednisone — DRUG
    Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
  • Vincristine — DRUG
    Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Study Details

This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)

Key Dates

Start date
Jan 31, 2010
Status verified
Dec 2013
Primary completion
Jun 30, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
164 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VR-CAP
    VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.
  • Active Comparator: R-CHOP
    R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone

Primary Outcome Measure

Complete Response (CR) Rate [ Time Frame: 6 cycles ]

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