Escalation Antifungal Prophylaxis for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 2

Conditions: Fungal Infection

Treatments: Drug: Escalating prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT04273178

2019-BMT-Prophyfungal

Details and patient eligibility

About

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 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.

Enrollment: 175 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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175 participants in 1 patient group

Escalating prophylaxis

Experimental group

Description:

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.

Treatment:

Drug: Escalating prophylaxis