NCT03821727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
441

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

January 19, 2019

Last Update Submit

January 26, 2019

Conditions

SCTPhiladelphia Positive Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS).

    as reported

    5 years

Secondary Outcomes (3)

  • Rate of complete cytologic remission (CR) before and after transplant.

    Baseline and 3 months after SCT

  • Rate of minimal residual disease (MRD).

    Baseline and 3 months post SCT

  • Cumulative incidence of extensive chronic graft versus host disease (cGVHD).

    5 years

Other Outcomes (3)

  • Progression-free survival (PFS).

    5 years

  • Cumulative incidence of relapse (CIR).

    5 years

  • Non-relapse mortality (NRM).

    5 years

Interventions

Hematopoietic Stem Cell TransplantationPROCEDURE

Hematopoietic Stem Cell Transplantation in Acute Leukemia Ph positive

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Genova, 16132, Italy

Location

University Hospital, Udine

Udine, 33100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 31400502DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Hematopoietic Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Renato Fanin, Professor

    University of Udine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

January 19, 2019

First Posted

January 30, 2019

Study Start

October 26, 2016

Primary Completion

December 31, 2017

Study Completion

June 30, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

IT(2)