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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03821727

Enrollment

441

Registered

2019-01-30

Start date

2016-10-26

Completion date

2018-06-30

Last updated

2019-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Philadelphia Positive Acute Lymphoblastic Leukemia, SCT

Brief 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.

Interventions

PROCEDUREHematopoietic Stem Cell Transplantation

Hematopoietic Stem Cell Transplantation in Acute Leukemia Ph positive

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival (OS).	5 years	as reported

Secondary

Measure	Time frame	Description
Rate of complete cytologic remission (CR) before and after transplant.	Baseline and 3 months after SCT	As reported
Rate of minimal residual disease (MRD).	Baseline and 3 months post SCT	As reported
Cumulative incidence of extensive chronic graft versus host disease (cGVHD).	5 years	as reported

Other

Measure	Time frame	Description
Cumulative incidence of relapse (CIR).	5 years	as reported
Non-relapse mortality (NRM).	5 years	as reported
Progression-free survival (PFS).	5 years	as reported

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026