Escalation Antifungal Prophylaxis for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04273178
Collaborator
(none)
175
1
1
29.5
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Escalating prophylaxis
Phase 2

Detailed Description

Based on CAESAR study, the IFD incidence increased significantly in patients with unrelated donor or hallo-donor HSCT after patients being discharged from LAF units. The overall incidence of IFD in patients with HLA-matched sibling donor remain low unless in patients with active aGVHD. In this single-arm prospective study, we plan to evaluate the feasibility and effect of 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
175 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Feasibility and Outcome of Anti-fungal Prophylaxis With an Escalation Pattern for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Actual Study Start Date :
Jan 15, 2020
Anticipated Primary Completion Date :
Jan 15, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Escalating prophylaxis

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
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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of IFD [day 180 after transplantation]

    Proven and probable diagnosis of IFD

Secondary Outcome Measures

  1. Incidence of IFD2 [day 180 after transplantation]

    Proven, probable and possible IFD

  2. Incidence of IFD associated mortality [day 180 after transplantation]

    Documentation of death due to proven, probable and possible IFD

  3. Incidence of nor-relapse mortality (NRM) [day 180 after transplantation]

    Documentation of death not due to disease relapse or progression

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Blood & Marrow Transplantation Center, RuiJin Hospital Shanghai Shanghai China 200025

Sponsors and Collaborators

  • Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Jiong Hu, Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiong HU, Head of Blood and Marrow Transplantation Program, Principle Investigator, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT04273178
Other Study ID Numbers:
  • 2019-BMT-Prophyfungal
First Posted:
Feb 17, 2020
Last Update Posted:
Nov 26, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jiong HU, Head of Blood and Marrow Transplantation Program, Principle Investigator, Shanghai Jiao Tong University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 26, 2021