Immuno-Chemotherapy (IC) and Autologous Stem Cell Transplant (ASCT) for Untreated Patients (pts) with Mantle Cell Lymphoma (MCL): CALGB 59909.


Conference Paper

Abstract We evaluated the feasibility, safety, and effectiveness of an intense IC regimen including ASCT in pts with untreated MCL up to age 70. The primary end-point was 2-year progression free survival (PFS). A successful protocol would demonstrate a 2-year PFS of 50% (95% CI 37, 63%) or better. MCL was confirmed by central pathology review plus either compatible immunophenotype, cyclin D1 over-expression, t(11;14) or bcl-1/IgH rearrangement. Treatment consisted of 2 cycles (3 if marrow has >=15% MCL after 2 cycles) of rituximab (R), methotrexate 300 mg/m2 (M) and augmented CHOP (2 g/m2 cyclophosphamide [C]) followed by consolidation and stem cell collection with EAR (etoposide [E] 40 mg/kg, cytarabine [A] 2 g/m2 for 8 doses, R for 2 doses, and filgrastim 10 mcg/kg/day beginning day14 until completion of stem cell collection). EAR was followed by ASCT using CBV (carmustine [B] 15 mg/kg, E 60 mg/kg, and C 100 mg/kg) followed by R 6 and 7 weeks after ASCT. 79 pts were enrolled in 40 months: median age 57 (37–69); 79% male; 33% elevated serum LDH; 73% bone marrow (+); 5% cerebrospinal fluid (+). 1 pt never received protocol therapy, 1 pt came off study for an allogeneic stem cell transplant, and 7 pts never underwent ASCT. Stem cell collection was excellent, with a median CD34-cell dose of 12x106/kg in median of 1 apheresis. There were 2 treatment-related deaths. The complete and partial response rates were 62% (49,74%) and 27% (17, 40%), respectively. With a median follow-up of 27.5 months, the PFS is 75% (61, 84%) at 2 years and 56% (39, 69%) at 3 years (intention to treat analysis). The overall survival is 82% (68, 90%) at 3 years. Intense IC plus ASCT is feasible, safe, and effective in pts with MCL. These results are comparable to single institution outcomes. Maintenance bortezomib will be added to this regimen post-ASCT in a successor CALGB trial.

Full Text

Duke Authors

Cited Authors

  • Damon, LE; Johnson, J; Niedzwiecki, D; Cheson, BD; Hurd, DD; Bartlett, NL; Byrd, JC; Kelly, M; Linker, C; Canellos, GP

Published Date

  • November 16, 2006

Published In

Volume / Issue

  • 108 / 11

Start / End Page

  • 2737 - 2737

Published By

Electronic International Standard Serial Number (EISSN)

  • 1528-0020

International Standard Serial Number (ISSN)

  • 0006-4971

Digital Object Identifier (DOI)

  • 10.1182/blood.v108.11.2737.2737