title: A phase 2 study of Rituximab-Bendamustine and Rituximab-Cytarabine for transplant-eligible patients with mantle cell lymphoma.
abstract: Chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) is a standard therapy for transplant-eligible patients with newly diagnosed mantle cell lymphoma (MCL). The achievement of complete remission (CR) and minimal residual disease (MRD) negativity are associated with better outcomes. We tested an induction regimen of rituximab/bendamustine followed by rituximab/high-dose cytarabine (RB/RC). This phase 2 study (NCT01661881) enrolled 23 transplant-eligible patients aged 42-69, of whom 70% were MCL international prognostic index low-risk. Patients received three cycles of RB followed by three cycles of RC. The primary endpoint of the trial was the rate of CR after six cycles of therapy, with a rate of 75% considered promising. 96% of patients achieved a CR/unconfirmed CR after treatment, meeting the primary objective. One patient progressed on study, one declined ASCT in CR, and the remaining 21 underwent successful stem cell collection and ASCT. After a median follow-up of 13 months, the progression-free survival rate was 96%. Among 15 MRD-evaluable patients who completed treatment, 93% achieved MRD negativity after RB/RC. In conclusion, RB/RC achieves very high CR and MRD negativity rates in transplant-eligible patients, with a favourable safety profile. RB/RC warrants further comparative studies, and may become a useful alternative to RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)-based induction regimens in this patient population.
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Philippe
authors.initials: P
authors.lastname: Armand
authors.affiliation: Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Redd
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Jad
authors.initials: J
authors.lastname: Bsat
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Sangeetha
authors.initials: S
authors.lastname: Mayuram
authors.affiliation: Department of Radiology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Angela
authors.initials: A
authors.lastname: Giardino
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Fisher
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Ann S
authors.initials: AS
authors.lastname: LaCasce
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Caron
authors.initials: C
authors.lastname: Jacobson
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Matthew S
authors.initials: MS
authors.lastname: Davids
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Brown
authors.affiliation: Sequenta Inc, South San Francisco, CA, USA.
authors.forename: Li
authors.initials: L
authors.lastname: Weng
authors.affiliation: Sequenta Inc, South San Francisco, CA, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Wilkins
authors.affiliation: Sequenta Inc, South San Francisco, CA, USA.
authors.forename: Malek
authors.initials: M
authors.lastname: Faham
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Arnold S
authors.initials: AS
authors.lastname: Freedman
authors.affiliation: Department of Medical Oncology, Beth Israel-Deaconess Medical Center, Boston, MA, USA.
authors.forename: Robin
authors.initials: R
authors.lastname: Joyce
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Jacobsen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000097:blood / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D000069283:Rituximab / Q000008:administration & dosage; D015996:Survival Rate
chemical_list: D003561:Cytarabine; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride
keywords: chemotherapy; clinical trials; malignant lymphomas