Escalation Antifungal Prophylaxis for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Overview

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.

Full Title of Study: “Feasibility and Outcome of Anti-fungal Prophylaxis With an Escalation Pattern for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 15, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of IFD
    • Time Frame: day 180 after transplantation
    • Proven and probable diagnosis of IFD

Secondary Measures

  • Incidence of IFD2
    • Time Frame: day 180 after transplantation
    • Proven, probable and possible IFD
  • Incidence of IFD associated mortality
    • Time Frame: day 180 after transplantation
    • Documentation of death due to proven, probable and possible IFD
  • Incidence of nor-relapse mortality (NRM)
    • Time Frame: day 180 after transplantation
    • Documentation of death not due to disease relapse or progression

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Jiao Tong University School of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jiong HU, Head of Blood and Marrow Transplantation Program, Principle Investigator – Shanghai Jiao Tong University School of Medicine
  • Overall Official(s)
    • Jiong Hu, Principal Investigator, Ruijin Hospital
  • Overall Contact(s)
    • Jiong Hu, 86-21-64370045, hj10709@rjh.com.cn

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.