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. 2016 Dec 31;109(1):djw263. doi: 10.1093/jnci/djw263

Table 2.

Recently reported and ongoing clinical trials in MCL*

Study Intensity Treatment Status/results
TRIANGLE (EMCL) Intensive Induction +/− consolidative auto vs ibrutinib; R-CHOP/DHAP → ASCT vs R-CHOP/DHAP + ibrutinib → ASCT → ibrutinib maintenance vs R-CHOP/DHAP + ibrutinib → ibrutinib maintenance Ongoing
S1106 Intensive A randomized phase II trial of R-HCVAD-MTX/ARA-C induction followed by consolidation with an autologous stem cell transplant vs R-bendamustine induction followed by consolidation with an autologous stem cell transplant for patients age ≤65 y with previously untreated mantle cell lymphoma Terminated
LYM-3002 Less intensive Randomized phase III study of R-CHOP vs bortezomib, rituximab, cyclophosphamide, doxorubicin, prednisone (VR-CAP), which showed significantly improved 2-year PFS in the VR-CAP arm Reported
S0601 Less intensive Single-arm phase II study of RCHOP plus bortezomib, improved PFS as compared with R-CHOP historical controls Reported
SHINE Less intensive Bendamustine-rituximab +/− ibrutinib or placebo followed by rituximab and ibrutinib maintenance in patients age > 65 y (Janssen sponsored, phase III, international study) Enrollment completed
E1411 (CTSU)/Intergroup Less intensive

  • Phase II four-arm study (initially only enrolled age ≥ 60 y, now open to all ages)

  • Arm A: bendamustine plus rituximab (BR) followed by rituximab (R consolidation) (BR→R)

  • Arm B: BR plus bortezomib (V) followed by R consolidation (BVR→R)

  • Arm C: BR followed by lenalidomide (L) plus R consolidation (BR→LR)

  • Arm D: BR plus bortezomib followed by R plus L consolidation (BVR→LR)

 Ongoing: expected to reach target accrual in third quarter of 2016
MCL elderly R2 (EMCL) Less intensive 8x R-CHOP vs 6x R-CHOP/R-DHA -> rituximab maintenance vs rituximab/lenalidomide (2 y) Ongoing
*

ASCT = autologous stem cell transplantation; BR = bendamustine plus rituximab; BVR = BR plus bortezomib; LR = lenalidomide plus R consolidation; MCL = mantle cell lymphoma; PFS = progression-free survival; R-CHOP/DHA = rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone/dexamethasone, high-dose cytarabine; R-CHOP/DHAP = rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, high-dose cytarabine, cisplatin.