NCT00722137

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, Multicenter Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone (VcR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Mantle Cell Lymphoma Who Are Not Eligible for a Bone Marrow Transplant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 487 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study were combination of VcR-CAP and R-CHOP. Combination of VcR-CAP and R-CHOP is being tested to treat people who had mantle cell lymphoma (MCL). The study enrolled 487 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in a 1:1 ratio: Treatment Group A (VcR-CAP) Treatment Group B (R-CHOP) The study included a screening phase, a treatment phase, a short-term follow-up phase, and a long-term follow-up phase. The screening phase was up to 28 days (56 days for bone marrow evaluation) prior to randomization. This multi-center trial was conducted worldwide. The total study duration from randomization of the first patient until the last progression-free survival (PFS) event required for the final analysis was expected to be approximately 42 months (24 months for enrollment and 18 months for follow-up) and survival follow-up every 12 weeks until death.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-05-01
• Primary completion: 2014-01-01
• Completion: 2017-06-17
• First posted: 2008-07-25
• Last updated: 2018-07-12
• Results posted: 2014-11-17

Locations

150 sites across 29 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

Regulatory

• FDA-regulated drug study