Escalation Antifungal Prophylaxis for Patients Undergoing Allogeneic

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04273178
Study type	Interventional
Source	Shanghai Jiao Tong University School of Medicine
Contact	Jiong Hu
Phone	86-21-64370045
Email	hj10709@rjh.com.cn
Status	Recruiting
Phase	Phase 2
Start date	January 15, 2020
Completion date	June 30, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03641131` - Ampholipad Real-World Data in Taiwan
Not yet recruiting	`NCT03292224` - Systemic Fungal Infections in ICU Patients	N/A
Completed	`NCT01371656` - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation	Phase 3
Completed	`NCT00936117` - Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia	Phase 2
Completed	`NCT00740389` - TMC125-TiDP2-C187: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Interaction Between TMC125 and Two Antifungal Agents (Fluconazole and Voriconazole), All at Steady-state in Healthy Subjects.	Phase 1
Completed	`NCT03857399` - Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin	Phase 2
Not yet recruiting	`NCT04215458` - Microbiota in Skin and Mucosa of Patients With Inflammatory Skin Diseases	N/A
Completed	`NCT03667690` - Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis	Phase 3
Completed	`NCT02957929` - Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally	Phase 1
Completed	`NCT01419678` - Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients	N/A
Recruiting	`NCT00333645` - Prophylaxis With Caspofungin in High-Risk Liver Transplantation	Phase 2
Not yet recruiting	`NCT03650439` - Fungal Infections in Patients With Hematological Malignancies
Completed	`NCT01303549` - Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients	Phase 4
Completed	`NCT00811642` - Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)	Phase 3
Withdrawn	`NCT00430469` - Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients	Phase 1/Phase 2
Terminated	`NCT00386997` - ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia	Phase 4
Completed	`NCT00514358` - Fluconazole Pharmacokinetics in Infants	Phase 1
Completed	`NCT04166669` - A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001	Phase 1
Recruiting	`NCT05150327` - Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
Completed	`NCT02387983` - Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117)	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Escalation Antifungal Prophylaxis for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms