Hematologic malignancy
Conditions
Interventions
VRCZ arm (for 60 days) VRCZ tablet: 200 mg twice daily between meals for patients 40 kg or more, 100 mg twice daily between meals for patients less than 40 kg. If oral drug administration is not
Sponsors
Grants from the Japanese Ministry of Health, Labor and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who undergo allogeneic HSCT. All disease types, donors, graft types, conditioning regimens were eligible. 2) Patients who developed one of the following GVHD: (A)grade II-IV acute GVHD, or (B)chronic GVHD that required 0.3 mg/kg/d or more prednisone (or equivalent steroid dose). 3) Patients who did not have proven or probable invasive fungal infection defined by the revised EORTC criteria at registration. Chest CT scan, galactomannan, and beta-D-glucan tests were required within 7 days before registration. 4) Absolute neutrophil count of 500/micro-L or more 5) Adequate hepatic function indicated by ALT level less than 5 times the upper limit of the normal range and total bilirubin level less than 2.5 mg/dL. 6) Adequate renal function indicated by creatinine clearance level 30 mL/min or more using Cockcroft&Gault formula. 7) Written informed consent obtained.
Exclusion criteria
Exclusion criteria: 1) Patients who had hypersensitivity against the study drugs. 2) Patients who received VRCZ or ITCZ within 7 days before registration. Patients who received antifungal drugs other than the study drugs (such as fluconazole and micafungin) can be registered if they discontinue the antifungal drugs before before registration. 3) Patients who had recurrent malignancies during the period from HSCT to registration. 4) Patients with chronic GVHD whose steroid dose was planed rapidly decreased within 3 weeks. 5) Patients who required medications that are contraindicated for the concurrent use of azoles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was the treatment success defined by the following criteria during the period from randomization to day 60: 1) alive 2) free from proven or probable invasive fungal infection defined by the revised EORTC criteria 3) able to continue the assigned drug for more than 80% of the study period (48 days or longer) | — |
Countries
Japan
Contacts
Public ContactTakahiro Fukuda
National Cancer Center Hospital Division of Hematopoietic Stem Cell Transplantation
Outcome results
None listed