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SCT in Ph Positive Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821727
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
Gruppo Italiano Trapianto di Midollo Osseo
Information provided by (Responsible Party):
CANDONI ANNA, University Hospital, Udine, Italy

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.

Condition or disease Intervention/treatment
Philadelphia Positive Acute Lymphoblastic Leukemia SCT Procedure: Hematopoietic Stem Cell Transplantation

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 441 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 10 Years
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)
Actual Study Start Date : October 26, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : June 30, 2018



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


Primary Outcome Measures :
  1. Overall Survival (OS). [ Time Frame: 5 years ]
    as reported


Secondary Outcome Measures :
  1. Rate of complete cytologic remission (CR) before and after transplant. [ Time Frame: Baseline and 3 months after SCT ]
    As reported

  2. Rate of minimal residual disease (MRD). [ Time Frame: Baseline and 3 months post SCT ]
    As reported

  3. Cumulative incidence of extensive chronic graft versus host disease (cGVHD). [ Time Frame: 5 years ]
    as reported


Other Outcome Measures:
  1. Progression-free survival (PFS). [ Time Frame: 5 years ]
    as reported

  2. Cumulative incidence of relapse (CIR). [ Time Frame: 5 years ]
    as reported

  3. Non-relapse mortality (NRM). [ Time Frame: 5 years ]
    as reported



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821727


Locations
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Italy
GITMO Centers and GITMO CLINICAL OFFICE-AOU-IRCSS San Martino-Ge
Genova, Italy, 16132
University Hospital, Udine
Udine, Italy, 33100
Sponsors and Collaborators
CANDONI ANNA
Gruppo Italiano Trapianto di Midollo Osseo
Investigators
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Principal Investigator: Renato Fanin, Professor University of Udine
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CANDONI ANNA, Principal Investigator, Clinical Professor, University Hospital, Udine, Italy
ClinicalTrials.gov Identifier: NCT03821727    
Other Study ID Numbers: PRN°0068937
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases