title: Allogeneic stem cell transplantation after conditioning with treosulfan, etoposide and cyclophosphamide for patients with ALL: a phase II-study on behalf of the German Cooperative Transplant Study Group and ALL Study Group (GMALL).
abstract: TBI-based preparative regimens are considered as standard conditioning therapy for allogeneic stem cell transplantation (AHSC) in patients with ALL. We investigated toxicity and efficacy of a non-TBI-based regimen consisting of treosulfan, etoposide and cyclophosphamide for ALL within a prospective study. Major inclusion criteria were CR and non-eligibility for TBI. Fifty patients with a median age of 46.5 years (range, 18-64) were included. Donors were HLA-identical sibling (n=8), matched (n=42) or mismatched (n=10) unrelated. The toxicity was moderate, resulting in a cumulative incidence of non-relapse mortality (NRM) at 1 year of 8% (90% confidence interval: 2-15%). Acute GvHD grade II-IV and grade III/IV was noted in 53% and 14%, respectively. Chronic GvHD at one year was seen in 41%. After a median follow-up of 24 months the cumulative incidence of relapse was 36% (90% confidence interval: 24-48) and 51% (90% confidence interval: 37-65) at 1 and 2 years, respectively. The estimated 2-year disease-free and overall survivals were 36 and 48%, respectively. Treosulfan, etoposide and cyclophosphamide followed by AHSC has a favorable toxicity profile with low NRM and therefore represents a potential alternative regimen for ALL in 1. CR (NCT00682305).
authors.affiliation: Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Kröger
authors.affiliation: Department of Hematology/Oncology, University Hospital Dresden, Dresen, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Bornhäuser
authors.affiliation: Department of Hematology/Oncology, University Hospital Münster, Münster, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Stelljes
authors.affiliation: CTS-Clinical Trial Solutions, Wedel, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Pichlmeier
authors.affiliation: Department of Bone Marrow Transplantation, University Hospital, Essen, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Trenschel
authors.affiliation: Department of Hematology/Oncology, Community Hospital, Augsburg, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Schmid
authors.affiliation: Department of Hematology/Oncology, University Hospital Charité, Berlin, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Arnold
authors.affiliation: Department of Hematology/Oncology, University Hospital, Frankfurt, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Martin
authors.affiliation: Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Heinzelmann
authors.affiliation: Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Wolschke
authors.affiliation: Department of Hematology/Oncology, University Medical Center Mainz, Mainz, Germany.
authors.forename: R G
authors.initials: RG
authors.lastname: Meyer
authors.affiliation: Department of Hematology/Oncology, University Hospital, Tübingen, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Bethge
authors.affiliation: Department of Hematology/Oncology, University Hospital, Düsseldorf, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Kobbe
authors.affiliation: Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Ayuk
authors.affiliation: Study Office German ALL Study Group (GMALL), Frankfurt, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Gökbuget
authors.affiliation: Study Office German ALL Study Group (GMALL), Frankfurt, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Hölzer
authors.affiliation: Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Zander
authors.affiliation: Department of Bone Marrow Transplantation, University Hospital, Essen, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Beelen
mesh_terms: D000293:Adolescent; D000328:Adult; D064591:Allografts; D002066:Busulfan / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006086:Graft vs Host Disease / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D019653:Myeloablative Agonists / Q000008:administration & dosage / Q000009:adverse effects*; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000401:mortality / Q000628:therapy; D033581:Stem Cell Transplantation; D019172:Transplantation Conditioning / Q000009:adverse effects / Q000379:methods*
chemical_list: D019653:Myeloablative Agonists; D005047:Etoposide; D003520:Cyclophosphamide; C018404:treosulfan; D002066:Busulfan