NCT03821727

SCT in Ph Positive Acute Lymphoblastic Leukemia

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 441 (actual)
• Sponsor: CANDONI ANNA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Philadelphia Positive Acute Lymphoblastic Leukemia
• SCT

Interventions

Type	Name	Description
PROCEDURE	Hematopoietic Stem Cell Transplantation	Hematopoietic Stem Cell Transplantation in Acute Leukemia Ph positive

Timeline

• Start date: 2016-10-26
• Primary completion: 2017-12-31
• Completion: 2018-06-30
• First posted: 2019-01-30
• Last updated: 2019-01-30

Locations

2 sites across 1 country: Italy