Escalation Antifungal Prophylaxis for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Fungal Infection Clinical Trial

Official title:

Feasibility and Outcome of Anti-fungal Prophylaxis With an Escalation Pattern for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04273178
• Other study ID #: 2019-BMT-Prophyfungal
• Status: Recruiting
• Phase: Phase 2
• Start date: January 15, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jiong Hu
• Phone: 86-21-64370045
• Email: hj10709[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: June 30, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses

Intervention

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.

Locations

Country	Name	City	State
China	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of IFD	Proven and probable diagnosis of IFD	day 180 after transplantation
Secondary	Incidence of IFD2	Proven, probable and possible IFD	day 180 after transplantation
Secondary	Incidence of IFD associated mortality	Documentation of death due to proven, probable and possible IFD	day 180 after transplantation
Secondary	Incidence of nor-relapse mortality (NRM)	Documentation of death not due to disease relapse or progression	day 180 after transplantation