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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04273178
Other study ID # 2019-BMT-Prophyfungal
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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