Escalation Antifungal Prophylaxis for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
- Conditions
- Fungal Infection
- Interventions
- Drug: Escalating prophylaxis
- Registration Number
- NCT04273178
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 175
- 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
- Imparied liver function with (AST or ALT>3ULN, TBil >2ULN)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Escalating prophylaxis 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.
- Primary Outcome Measures
Name Time Method Incidence of IFD day 180 after transplantation Proven and probable diagnosis of IFD
- Secondary Outcome Measures
Name Time Method Incidence of IFD2 day 180 after transplantation Proven, probable and possible IFD
Incidence of IFD associated mortality day 180 after transplantation Documentation of death due to proven, probable and possible IFD
Incidence of nor-relapse mortality (NRM) day 180 after transplantation Documentation of death not due to disease relapse or progression
Trial Locations
- Locations (1)
Blood & Marrow Transplantation Center, RuiJin Hospital
🇨🇳Shanghai, Shanghai, China