Adult patients receiving allo-Stem Cell Transplantation using Cord Blood as source of stem cells MedDRA version: 18.0 Level: PT Classification code 10010980 Term: Cord blood transplant therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.0 Level: PT Classification code 10049085 Term: Antifungal prophylaxis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Micafungine
Pharmaceutical Form: Solution for injection
Sponsors
CHU de Nantes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: •Adult patients receiving allo-Stem Cell Transplantation using Cord Blood as source of stem cells (cf conditioning regimen recommendation). •Sex male or female •Age between 18 and 65 years at the time of signing the informed consent form. •Diagnosis of an hematologic disease for who a allograft decision has been taken ? not having a (HLA)-matched related or unrelated donor within two month after complete remission achievement •Able to understand and voluntarily sign an informed consent form. •Subjects affiliated with an appropriate social security system •Male, female without childbearing potential or negative urine pregnancy test at the screening visit prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures. Men must agree to use an acceptable method of contraception (for themselves or female partners) for the duration of the study •Each subject will weigh 40 kg or more Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria •Any suspected or documented invasive fungal infection at study entry or at any time prior to study entry •Use of any systemic antifungal therapy within 72 hours prior to study entry •Known history of allergy, hypersensitivity or intolerance to echinocandin agents •Patient with any medical, psychological or social condition, which in the opinion of the investigator could increase the risk to the patient, or decrease the chance of obtaining satisfactory data to achieve the objectives of this study. •Previous participation in this study. •HIV, HBV or HCV positive •Pregnant or breast feeding females. •Subject protected by law.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this pilot multicenter study will aim at assessing the safety of micafungin in patients receiving allo-SCT using CB as source of stem cells from the start of prophylaxis until the end of the 4-week post-treatment period.;Secondary Objective: The secondary objectives of the study will aim at assessing the efficacy of micafungin in preventing fungal infection.;Primary end point(s): Primary endpoint: - Safety assessed by the incidence and type of adverse events (AE) occurring during the course of prophylaxis treatment, AE related to study drug, AE leading to study drug discontinuation, and evolution of vital signs and biological parameters. ;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: -Incidence of Invasive Fungal Infection (IFI) at the end of prophylaxis period and at the end of the 4-week follow-up period -Incidence of fever of unknown origin requiring empirical antifungal treatment during prophylaxis period -Survival rate and incidence of mortality related to IFI from the start of prophylaxis until the end of the 4-week follow-up period. ;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
France
Contacts
Public ContactDirection de la recherche
CHU de Nantes
Outcome results
None listed