Escalation Antifungal Prophylaxis for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Last updated: November 23, 2021
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

2

Condition

Yeast Infections

Sunspot Fungus (Tinea Versicolor)

Systemic Fungal Infections

Treatment

N/A

Clinical Study ID

NCT04273178
2019-BMT-Prophyfungal
  • Ages 16-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 175
Study Start date:
January 15, 2020
Estimated Completion Date:
June 30, 2022

Study 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.

Connect with a study center

  • Blood & Marrow Transplantation Center, RuiJin Hospital

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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