|Canadian Cancer Trials Group LYC.1 (ECOG E1411) -- Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB → LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV → LR) -- was centrally activated March 12, 2014.
Primary objectives include to determine whether the addition of:
- bortezomib (RBV) to an induction regimen of rituximab-bendamustine (RB) improves progression-free survival (PFS) compared to RB alone in patients with previously untreated mantle cell lymphoma; and,
- lenalidomide to a consolidation regimen of rituximab following an induction regimen of RB or RBV improves PFS compared to consolidation rituximab alone in this patient population.
Secondary objectives include to determine:
- whether the addition of bortezomib to induction therapy improves the PET-documented complete response rate compared to RB alone;
- the objective response rate (ORR) for RB and RBV;
- among patients who do not have PET-documented CR at the end of induction, whether the addition of lenalidomide to consolidation therapy improves CR and ORR compared with rituximab alone;
- overall survival (OS) in the treatment arms; and,
- safety, with attention to the addition of bortezomib in the induction regimen and lenalidomide-rituximab as consolidation therapy.
Interested investigators and centres should contact Magda Monreal, Study Coordinator, at email@example.com or 613-533-6430.