SCT in Ph Positive Acute Lymphoblastic Leukemia

Completed

• Conditions: SCT; Philadelphia Positive Acute Lymphoblastic Leukemia

• Registration Number: NCT03821727
• Lead Sponsor: CANDONI ANNA

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.

Study Timeline

• Study Start: 2016-10-26
• Primary Completion: 2017-12-31
• Study Completion: 2018-06-30
• Status Verified: 2019-01
• Study First Submitted: 2019-01-19
• Study First Submitted QC: 2019-01-26
• Last Update Submitted: 2019-01-26
• Study First Posted: 2019-01-30
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS).	5 years	as reported

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of extensive chronic graft versus host disease (cGVHD).	5 years	as reported
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

Trial Locations

Locations (2)

University Hospital, Udine; 🇮🇹 Udine, Italy

GITMO Centers and GITMO CLINICAL OFFICE-AOU-IRCSS San Martino-Ge; 🇮🇹 Genova, Italy