NCT04273178

Brief Summary

This is single arm study to evaluate an escalation anti-fungal prophylaxis protocol for patients undergoing allogeneic stem cell transplantation. For all patients without documented proven or probable invasive fungal disease (IFD), patients will receive fluconazole during the treatment in the laminar air flow units (LAF). After discharged from LAF units, patients will receive anti-mold prophylaxis in case of haplo-identical or HLA-matched unrelated donor transplantation to d+100 without active acute GVHD (aGVHD). In case of active aGVHD, the prophylaxis treatment will be extended until recovery of aGVHD and tapering of immunosuppression. In case of HLA-matched sibling donor, fluconazole will be continued to d+100 and anti-mold prophylaxis will be given in case of active aGVHD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

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 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

February 14, 2020

Last Update Submit

November 23, 2021

Conditions

Fungal Infection

Keywords

fungal infection, stem cell transplantation, prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Incidence of IFD

    Proven and probable diagnosis of IFD

    day 180 after transplantation

Secondary Outcomes (3)

  • Incidence of IFD2

    day 180 after transplantation

  • Incidence of IFD associated mortality

    day 180 after transplantation

  • Incidence of nor-relapse mortality (NRM)

    day 180 after transplantation

Study Arms (1)

Escalating prophylaxis

EXPERIMENTAL

For all patients without documented proven or probable invasive fungal disease (IFD), patients will receive fluconazole during the treatment in the laminar air flow units (LAF). After discharged from LAF units, patients will receive anti-mold prophylaxis in case of haplo-identical or HLA-matched unrelated donor transplantation to d+100 without active acute GVHD (aGVHD). In case of active aGVHD, the prophylaxis treatment will be extended until recovery of aGVHD and tapering of immunosuppression. In case of HLA-matched sibling donor, fluconazole will be continued to d+100 and anti-mold prophylaxis will be given in case of active aGVHD.

Drug: Escalating prophylaxis

Interventions

Escalating prophylaxisDRUG

For all patients without documented proven or probable invasive fungal disease (IFD), patients will receive fluconazole during the treatment in the laminar air flow units (LAF). After discharged from LAF units, patients will receive anti-mold prophylaxis in case of haplo-identical or HLA-matched unrelated donor transplantation to d+100 without active acute GVHD (aGVHD). In case of active aGVHD, the prophylaxis treatment will be extended until recovery of aGVHD and tapering of immunosuppression. In case of HLA-matched sibling donor, fluconazole will be continued to d+100 and anti-mold prophylaxis will be given in case of active aGVHD.

Escalating prophylaxis

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergo allogeneic HSCT
  • Conditioning regimens: myelo-ablative, reduced toxicity
  • No proven or probable IFD before HSCT
  • No allergy to fluconazole, voriconazle and posaconazole
  • Inform consent given

You may not qualify if:

  • Imparied liver function with (AST or ALT\>3ULN, TBil \>2ULN)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Jiong Hu

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong Hu

CONTACT

86-21-64370045hj10709@rjh.com.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Blood and Marrow Transplantation Program, Principle Investigator

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 17, 2020

Study Start

January 15, 2020

Primary Completion

January 15, 2022

Study Completion

June 30, 2022

Last Updated

November 26, 2021

Record last verified: 2021-11

Locations

CN(1)