Philadelphia Positive Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Outcome of Hematopoietic Stem Cell Transplantation in Philadelphia Positive Acute Lymphoblastic Leukemia in the Era of Tyrosine Kinase Inhibitors. A Registry-based Study of the Italian Blood and Marrow Transplantation Society (GITMO)
This study includes a registry-based, nationwide analysis to describe the clinical outcome of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who underwent an allogeneic hematopoietic stem cell transplantation (HSCT) after a Tyrosine Kinase Inhibitors (TKI)-based treatment.
This was a retrospective nationwide analysis based on registry data collected by GITMO.
Inclusion criteria were: 1) diagnosis of Ph+ ALL; age ≥18 years at transplant; 2) patients
receiving first allogeneic HSCT from any donor (HLA-identical sibling donor (MSD), unrelated
donor (UD) or alternative donor (haploidentical or cord blood) between 2005 and 2016 in a
GITMO center; 3) TKI-based treatment prior to HSCT; 4) patients with available pre-transplant
MRD status, as well as complete clinical data and outcome. Data were extracted from the GITMO
Registry (PROMISE Registry).
The endpoints of the study were: OS, progression-free survival (PFS), cumulative incidence of
relapse (CIR), non-relapse mortality (NRM), cumulative incidence of extensive chronic graft
versus host disease (cGVHD), rate of minimal residual disease (MRD) negativity and the rate
of complete cytologic remission (CR) before and after transplant.
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