Mantle Cell Lymphoma Clinical Trial
Official title:
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
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.
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.
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