SCT in Ph Positive Acute Lymphoblastic Leukemia

NCT ID: NCT03821727

Last Updated: 2019-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

441 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-26

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Philadelphia Positive Acute Lymphoblastic Leukemia SCT

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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Hematopoietic Stem Cell Transplantation

Hematopoietic Stem Cell Transplantation in Acute Leukemia Ph positive

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Trapianto di Midollo Osseo

OTHER

Sponsor Role collaborator

CANDONI ANNA

OTHER

Sponsor Role lead

Responsible Party

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CANDONI ANNA

Principal Investigator, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Renato Fanin, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Udine

Locations

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GITMO Centers and GITMO CLINICAL OFFICE-AOU-IRCSS San Martino-Ge

Genova, , Italy

Site Status

University Hospital, Udine

Udine, , Italy

Site Status

Countries

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Italy

References

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Candoni A, Rambaldi A, Fanin R, Velardi A, Arcese W, Ciceri F, Lazzarotto D, Lussana F, Olivieri J, Grillo G, Parma M, Bruno B, Sora F, Bernasconi P, Saccardi R, Foa R, Sessa M, Bresciani P, Giglio F, Picardi A, Busca A, Sica S, Perruccio K, Zucchetti E, Diral E, Iori AP, Colombo AA, Tringali S, Santarone S, Irrera G, Mancini S, Zallio F, Malagola M, Albano F, Carella AM, Olivieri A, Tecchio C, Dominietto A, Vacca A, Sorasio R, Orciuolo E, Risitano AM, Leotta S, Cortelezzi A, Mammoliti S, Oldani E, Bonifazi F; GITMO. Outcome of Allogeneic Hematopoietic Stem Cell Transplantation in Adult Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia in the Era of Tyrosine Kinase Inhibitors: A Registry-Based Study of the Italian Blood and Marrow Transplantation Society (GITMO). Biol Blood Marrow Transplant. 2019 Dec;25(12):2388-2397. doi: 10.1016/j.bbmt.2019.07.037. Epub 2019 Aug 7.

Reference Type DERIVED
PMID: 31400502 (View on PubMed)

Other Identifiers

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PRN°0068937

Identifier Type: -

Identifier Source: org_study_id

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