30 adult patients due to receive an allograft for a myeloid or lymphoid hematological malignancy with an HLA-matched donor from the family or from the international donor file will be included in the hematology departments of the Nantes University Hospital.
Conditions
Brief summary
The primary endpoint is plasma residual posaconazole concentration ([C]min), measured on day 8 of posaconazole initiation. A [C]min > 0.7mg/l is considered effective
Detailed description
Monitoring of residual plasma concentrations [C]min up to Day 100, a)clinical record taken 2/week during hospitalization and then 1/week to describe clinical symptoms leading to malabsorption:nausea,vomiting,diarrhea,mucositis,colitis. Symptom intensity will be assessed (NCI CTCAE v5), b)Adherence to treatment monitored daily during hospitalization (paramedical staff). Once home, adherence assessed 1/week by the doctor in charge of the patient, c)All co-medications recorded throughout course of posaconazole treatment, based on data from patient's medical record, The physician in charge of the patient should specify the reason(s) for IV administration of the treatment, Description of situations leading to initial non-administration or early discontinuation of posaconazole, Description of posaconazole-related toxicities according to NCI CTCAE v5 classification, a)Engraftment assessed on hematological reconstitution (number of days of aplasia with PNN <0.5 G/L and platelets < 20, number of platelet and cell transfusions), b) OS : Survival between day 0 of transplantation and date of death or last follow-up, c) DFS : Survival between day 0 of transplant and date of relapse, death or last follow-up, d) NRM : Any death unrelated to relapse or disease progression, e) Any documented disease recurrence, f) Acute GVH grade 2-4 according to Mount Sinai criteria, g) Extensive chronic GVH according to NCI criteria, h) GRFS: Median relapse-free survival without grade 3-4 acute GVHD or chronic GVHD requiring systemic treatment, Post-transplant grade 3 and 4 adverse events (dates of occurrence) (NCI CTCAE version 5 criteria)
Interventions
DRUGPOSACONAZOLE
Sponsors
Centre Hospitalier Universitaire De Nantes
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is plasma residual posaconazole concentration ([C]min), measured on day 8 of posaconazole initiation. A [C]min > 0.7mg/l is considered effective | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitoring of residual plasma concentrations [C]min up to Day 100, a)clinical record taken 2/week during hospitalization and then 1/week to describe clinical symptoms leading to malabsorption:nausea,vomiting,diarrhea,mucositis,colitis. Symptom intensity will be assessed (NCI CTCAE v5), b)Adherence to treatment monitored daily during hospitalization (paramedical staff). Once home, adherence assessed 1/week by the doctor in charge of the patient, c)All co-medications recorded throughout course of posaconazole treatment, based on data from patient's medical record, The physician in charge of the patient should specify the reason(s) for IV administration of the treatment, Description of situations leading to initial non-administration or early discontinuation of posaconazole, Description of posaconazole-related toxicities according to NCI CTCAE v5 classification, a)Engraftment assessed on hematological reconstitution (number of days of aplasia with PNN <0.5 G/L and platelets < 20, number o | — |
Countries
France
Outcome results
None listed