Fungal Infection
Conditions
Keywords
fungal infection, stem cell transplantation, prophylaxis
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.
Interventions
DRUGEscalating 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.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of IFD | day 180 after transplantation | Proven and probable diagnosis of IFD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactJiong Hu
Outcome results
None listed