NCT03014934

Brief Summary

Via a prospective non-interventional study clinical outcome of patients with - and without - history of pre-existing invasive aspergillosis undergoing allo-HSCT will be assessed, in terms of non-relapse mortality overall mortality and fungal infectious morbidity. Aim. Assessment of 1-year outcome of patients undergoing allo-HSCT with history of pre-existing IA vs. no pre-existing IA. Hypothesis. NRM in patients with pre-existing IA is not higher (by a specified margin of 10%) than patients without pre-existing IA. Study population. First allo-HSCT in patients with acute leukaemia and MDS given stem cell grafts. Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of probable or proven invasive aspergillosis: this cohort includes also the patient with a history of possible mycosis not documented microbiologically.

Trial Health

50
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
6 countries

8 active sites

Status
unknown

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

January 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

5.7 years

First QC Date

January 6, 2017

Last Update Submit

January 13, 2021

Conditions

Invasive Aspergillosis

Keywords

AspergillosisIA

Outcome Measures

Primary Outcomes (1)

  • Non-relapse mortality

    One year non-relapse mortality cumulative incidence

    1 year

Secondary Outcomes (5)

  • Relapse free survival

    1 year

  • Overall survival

    1 year

  • Incidence and severity of Graft versus Host Disease

    1 year

  • Incidence of relapse

    1 year

  • Status of Invasive Aspergillosis

    1 year

Study Arms (2)

Cases: Prior Invasive Aspergillosis

History of probable or proven Invasive Aspergillosis according to EORTC 2008 criteria

Controls: No prior proven Invasive Aspergillosis

Patients really negative for Invasive Aspergillosis and those with possible Invasive Aspergillosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

First allo-HSCT in patients with acute leukaemia and MDS given stem cell grafts.

You may qualify if:

  • First allo-HSCT
  • Acute leukaemia or MDS
  • Received stem cell grafts

You may not qualify if:

  • History, in the 6 months preceding HSCT, or documented presence of Invasive candida or mould infections other than IA (Mucor, Fusariosis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Institute G. Gaslini

Genova, 16148, Italy

RECRUITING

Clinica di Oncoematologia Pediatrica

Padua, 35128, Italy

RECRUITING

Ospedale Infantile Regina Margherita

Torino, 10126, Italy

RECRUITING

King Faisal Specialist Hospital & Research Centre

Riyadh, 11211, Saudi Arabia

RECRUITING

Hospital Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

University Hospital

Basel, 4031, Switzerland

RECRUITING

Gazi University School of Medicine

Ankara, 06500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Aspergillosis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Olaf Penack, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

  • Jan Styczynski

    University Hospital, Collegium Medicum UMK

    STUDY CHAIR

Central Study Contacts

Jennifer Hoek, MD

CONTACT

+31715265668j.d.c.hoek@lumc.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 9, 2017

Study Start

January 1, 2016

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)DE(1)TU(1)IT(3)ES(1)CH(1)