Escalation Antifungal Prophylaxis for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Fluconazole

Criteria

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)