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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Millennium Pharmaceuticals, Inc.
Study ID
NCT00722137
Phase
PHASE3
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Rituximab 375 mg/m^2 — DRUG
    Intravenous rituximab 375 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles.
  • Cyclophosphamide 750 mg/m^2 — DRUG
    Intravenous cyclophosphamide 750 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles
  • Doxorubicin 50 mg/m^2 — DRUG
    Intravenous doxorubicin 50 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles
  • VELCADE 1.3 mg/m^2 — DRUG
    Intravenous VELCADE 1.3 mg/m\^2 on Days 1,4,8, and 11of a 21-day (3 week) cycle for 6 cycles
  • Prednisone 100 mg/m^2 — DRUG
    Oral prednisone 100 mg/m\^2 on Day 1 to Day 5 of a 21-day (3 week) cycle for 6 cycles
  • Vincristine 1.4 mg/m^2 — DRUG
    Intravenous vincristine 1.4 mg/m\^2 on Day 1of a 21-day (3 week) cycle for 6 cycles. Maximum of 2 mg. Participants could receive 8 cycles if a response was initially documented at the Cycle 6 assessment.

Study Details

This is a randomized, open-label, multicenter, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation.

Key Dates

Start date
May 1, 2008
Status verified
Jun 2018
Primary completion
Jan 1, 2014
Completion
Jun 17, 2017

Study Design

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

Arms

  • Active Comparator: R-CHOP
    Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, Vincristine 1.4 mg/m\^2, and Prednisone 100 mg/m\^2
  • Experimental: VcR-CAP
    Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, VELCADE 1.3 mg/m\^2, and Prednisone 100 mg/m\^2

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Median duration of follow-up of 40 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
St. Francis Hosptial and Medical CenterHartfordConnecticut06105-
Center for Cancer Care at Goshen HospitalGoshenIndiana46526-
Sinai HospitalBaltimoreMaryland21215-
Capitol Comp. Cancer CenterJefferson CityMissouri65109-
Nebraska Cancer SpecialistsOmahaNebraska68114-
Hematology-Oncology Associates of Northern NJMorristownNew Jersey07960-
Legacy Pharma ResearchBismarckNorth Dakota58501-
Division of Hematology and Oncology Vanderbilt UniversityNashvilleTennessee37232-
Cancer Outreach Associates, PCAbingdonVirginia24211-

Find similar trials in Hartford, CT

By research site
St. Francis Hosptial and Medical Center· Hartford, CTCenter for Cancer Care at Goshen Hospital· Goshen, INSinai Hospital· Baltimore, MDCapitol Comp. Cancer Center· Jefferson City, MONebraska Cancer Specialists· Omaha, NEHematology-Oncology Associates of Northern NJ· Morristown, NJ

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