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Completed

NCT Number: NCT03821727

SCT in Ph Positive Acute Lymphoblastic Leukemia

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.

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Key information

Conditions

Philadelphia Positive Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma SCT

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GITMO Centers and GITMO CLINICAL OFFICE-AOU-IRCSS San Martino-Ge, Genova, Italy

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hematopoietic Stem Cell Transplantation

Procedure

Hematopoietic Stem Cell Transplantation in Acute Leukemia Ph positive

Primary outcomes

  1. Overall Survival (OS).

    Time frame: 5 years

    as reported

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CANDONI ANNA

Other

Collaborators

  • Gruppo Italiano Trapianto di Midollo Osseo

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 30, 2019
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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