SCT in Ph Positive Acute Lymphoblastic Leukemia

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03821727
• Other study ID #: PRN°0068937
• Status: Completed
• Start date: October 26, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2019
• Source: University Hospital, Udine, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Philadelphia Positive Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• SCT

Intervention

Procedure:
• Hematopoietic Stem Cell Transplantation
Hematopoietic Stem Cell Transplantation in Acute Leukemia Ph positive

Locations

Country	Name	City	State
Italy	GITMO Centers and GITMO CLINICAL OFFICE-AOU-IRCSS San Martino-Ge	Genova
Italy	University Hospital, Udine	Udine

Sponsors (2)

Lead Sponsor	Collaborator
CANDONI ANNA	Gruppo Italiano Trapianto di Midollo Osseo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression-free survival (PFS).	as reported	5 years
Other	Cumulative incidence of relapse (CIR).	as reported	5 years
Other	Non-relapse mortality (NRM).	as reported	5 years
Primary	Overall Survival (OS).	as reported	5 years
Secondary	Rate of complete cytologic remission (CR) before and after transplant.	As reported	Baseline and 3 months after SCT
Secondary	Rate of minimal residual disease (MRD).	As reported	Baseline and 3 months post SCT
Secondary	Cumulative incidence of extensive chronic graft versus host disease (cGVHD).	as reported	5 years