title: Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL.
abstract: Persistence or recurrence of minimal residual disease (MRD) after chemotherapy results in clinical relapse in patients with acute lymphoblastic leukemia (ALL). In a phase 2 trial of B-lineage ALL patients with persistent or relapsed MRD, a T cell-engaging bispecific Ab construct induced an 80% MRD response rate. In the present study, we show that after a median follow-up of 33 months, the hematologic relapse-free survival of the entire evaluable study cohort of 20 patients was 61% (Kaplan-Meier estimate). The hema-tologic relapse-free survival rate of a subgroup of 9 patients who received allogeneic hematopoietic stem cell transplantation after blinatumomab treatment was 65% (Kaplan-Meier estimate). Of the subgroup of 6 Philadelphia chromosome-negative MRD responders with no further therapy after blinatumomab, 4 are in ongoing hematologic and molecular remission. We conclude that blinatumomab can induce long-lasting complete remission in B-lineage ALL patients with persistent or recurrent MRD. The original study and this follow-up study are registered at www.clinicaltrials.gov as NCT00198991 and NCT00198978, respectively.
authors.affiliation: Department of Internal Medicine II, University Würzburg, Würzburg, Germany. topp_m@klinik.uni-wuerzburg.de.
authors.forename: Max S
authors.initials: MS
authors.lastname: Topp
authors.forename: Nicola
authors.initials: N
authors.lastname: Gökbuget
authors.forename: Gerhard
authors.initials: G
authors.lastname: Zugmaier
authors.forename: Evelyn
authors.initials: E
authors.lastname: Degenhard
authors.forename: Marie-Elisabeth
authors.initials: ME
authors.lastname: Goebeler
authors.forename: Matthias
authors.initials: M
authors.lastname: Klinger
authors.forename: Svenja A
authors.initials: SA
authors.lastname: Neumann
authors.forename: Heinz A
authors.initials: HA
authors.lastname: Horst
authors.forename: Thorsten
authors.initials: T
authors.lastname: Raff
authors.forename: Andreas
authors.initials: A
authors.lastname: Viardot
authors.forename: Matthias
authors.initials: M
authors.lastname: Stelljes
authors.forename: Markus
authors.initials: M
authors.lastname: Schaich
authors.forename: Rudolf
authors.initials: R
authors.lastname: Köhne-Volland
authors.forename: Monika
authors.initials: M
authors.lastname: Brüggemann
authors.forename: Oliver G
authors.initials: OG
authors.lastname: Ottmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Burmeister
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Baeuerle
authors.forename: Dirk
authors.initials: D
authors.lastname: Nagorsen
authors.forename: Margit
authors.initials: M
authors.lastname: Schmidt
authors.forename: Hermann
authors.initials: H
authors.lastname: Einsele
authors.forename: Gert
authors.initials: G
authors.lastname: Riethmüller
authors.forename: Michael
authors.initials: M
authors.lastname: Kneba
authors.forename: Dieter
authors.initials: D
authors.lastname: Hoelzer
authors.forename: Peter
authors.initials: P
authors.lastname: Kufer
authors.forename: Ralf C
authors.initials: RC
authors.lastname: Bargou
mesh_terms: D000328:Adult; D018033:Antibodies, Bispecific / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D053208:Kaplan-Meier Estimate; D018365:Neoplasm, Residual; D015452:Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / Q000097:blood / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D012008:Recurrence; D016019:Survival Analysis; D014184:Transplantation, Homologous
chemical_list: D018033:Antibodies, Bispecific; D000970:Antineoplastic Agents; C510808:blinatumomab