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.

Inclusion Criteria:

• Diagnosis of Ph+ ALL; age ≥18 years at transplant.
• 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.
• TKI-based treatment prior to HSCT.
• Patients with available pre-transplant MRD status, as well as complete clinical data and outcome.

Exclusion Criteria:

• All cases without one or more of inclusion criteria.

Data were extracted from the GITMO Registry (PROMISE Registry). All patients received a first allogeneic HSCT from any donor.

Data were extracted from the GITMO Registry (PROMISE Registry). All patients included in the registry signed an informed consent form. The study was conducted in compliance with current national and European legislation on clinical trials, in accordance with the Helsinki Declaration and the principles of good clinical practice (GCP). This study was approved by the GITMO board and by the institutional review board of the coordinating center (Hematology-University of Udine) and from institutional review boards of all participating centers.