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Although induction immunochemotherapy including high‐dose cytarabine and rituximab followed by high‐dose chemotherapy ( HDC ) with autologous stem cell transplantation ( ASCT ) is recommended for younger patients (≤65 years old) with untreated mantle cell lymphoma ( MCL ), no standard induction and  HDC  regimen has been established. We conducted a phase  II  study of induction immunochemotherapy of R‐High‐ CHOP / CHASER  followed by  HDC  of  LEED  with  ASCT  in younger patients with untreated advanced  MCL . Eligibility criteria included untreated  MCL , stage  II  bulky to  IV , and age 20‐65 years. Patients received 1 cycle of R‐High‐ CHOP  followed by 3 cycles of  CHASER  every 3 weeks. Peripheral blood stem cells ( PBSC ) were harvested during  CHASER .  LEED  with  ASCT  was delivered to patients who responded to R‐High‐ CHOP / CHASER . Primary endpoint was 2‐year progression‐free survival ( PFS ). From June 2008 to June 2012, 45 patients (median age 59 years; range 38‐65 years) were enrolled.  PBSC  were successfully harvested from 36 of 43 patients. Thirty‐five patients completed  ASCT . Two‐year  PFS  was 77% (80%  CI  68‐84), which met the primary endpoint. Five‐year  PFS  and overall survival were 52% (95%  CI  34‐68%) and 71% (95%  CI  51‐84%), respectively. Overall response and complete response rates after induction immunochemotherapy were 96% and 82%, respectively. The most common grade 4 toxicities were hematological. In younger patients with untreated  MCL , R‐High‐ CHOP / CHASER / LEED  with  ASCT  showed high efficacy and acceptable toxicity, and it can now be considered a standard treatment option.

R‐High‐ CHOP / CHASER / LEED with autologous stem cell transplantation in newly diagnosed mantle cell lymphoma: JCOG0406 STUDY