SCT in Ph Positive Acute Lymphoblastic Leukemia

January 26, 2019 updated by: CANDONI ANNA

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

441

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy, 16132
        • GITMO Centers and GITMO CLINICAL OFFICE-AOU-IRCSS San Martino-Ge
      • Udine, Italy, 33100
        • University Hospital, Udine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS).
Time Frame: 5 years
as reported
5 years

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CANDONI ANNA

Collaborators

Gruppo Italiano Trapianto di Midollo Osseo

Investigators

  • Principal Investigator: Renato Fanin, Professor, University of Udine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

January 19, 2019

First Submitted That Met QC Criteria

January 26, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 26, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRN°0068937

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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