Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD)

Nantes University Hospital (NUH)

Status and phase

Completed

Phase 2

Conditions

Invasive Fungal Infection

Treatments

Drug: Micafungin

Study type

Interventional

Funder types

Other

Identifiers

NCT01888458

RC13_0008

Details and patient eligibility

About

Infections due to post transplant immune deficiency are a major problem following allogeneic stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood transplant (CB). Duration of neutropenia is one of the most important risk factor for invasive fungal infection (IFI). In this setting, Micafungin has been approved for antifungal prophylaxis for patients undergoing Allo-SCT. In a randomized, double-blind, comparative, phase III trial, the overall efficacy of micafungin was superior to that of fluconazole as antifungal prophylaxis during the neutropenic phase after Allo-SCT. However, very few patients in this study received a CB transplant.

This is phase IIb, prospective, open-label, non-comparative study to assess the safety of micafungin when use in prevention of IFI in neutropenic patients receiving allo-SCT using CB as source of stem cells.

Enrollment

21 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

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.
Participation in a study testing a new drug or a new conditioning
HIV, HBV or HCV positive
Pregnant or breast feeding females.
Subject protected by law.