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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

NCT00722137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 487

Last updated 2018-07-12

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Rituximab 375 mg/m^2

Intravenous rituximab 375 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles.

DRUG

Cyclophosphamide 750 mg/m^2

Intravenous cyclophosphamide 750 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles

DRUG

Doxorubicin 50 mg/m^2

Intravenous doxorubicin 50 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles

DRUG

VELCADE 1.3 mg/m^2

Intravenous VELCADE 1.3 mg/m\^2 on Days 1,4,8, and 11of a 21-day (3 week) cycle for 6 cycles

DRUG

Prednisone 100 mg/m^2

Oral prednisone 100 mg/m\^2 on Day 1 to Day 5 of a 21-day (3 week) cycle for 6 cycles

DRUG

Vincristine 1.4 mg/m^2

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.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    collaborator INDUSTRY

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-01
Primary Completion
2014-01-01
Completion
2017-06-17
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Czechia
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Malaysia
  • Morocco
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Singapore
  • South Africa
  • Spain
  • Taiwan
  • Thailand
  • Tunisia
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00722137 on ClinicalTrials.gov