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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01888458

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Fungal Infection	Drug: Micafungin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Micafungine	Drug: Micafungin All patients meeting selection criteria will receive micafungin IV. Prophylaxis will start within 48 hours of the beginning of the transplant-related conditioning regimen until 5 days after recovery from neutropenia (ANC ≥ 500/µl), or occurrence of an IFI, or up to 42 days, or withdrawal for any reason (e.g. patient's or investigator's decision, development of intolerance, death), whichever come first

Arm

Intervention/Treatment

Experimental: Micafungine

Drug: Micafungin

All patients meeting selection criteria will receive micafungin IV. Prophylaxis will start within 48 hours of the beginning of the transplant-related conditioning regimen until 5 days after recovery from neutropenia (ANC ≥ 500/µl), or occurrence of an IFI, or up to 42 days, or withdrawal for any reason (e.g. patient's or investigator's decision, development of intolerance, death), whichever come first

Outcome Measures

Primary Outcome Measures

Safety [50 days]
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.

Secondary Outcome Measures

Incidence of Invasive Fungal Infection [50 days]
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 [50 days]
Incidence of fever of unknown origin requiring empirical antifungal treatment during prophylaxis period
Survival rate [50 days]
Survival rate and incidence of mortality related to IFI from the start of prophylaxis until the end of the 4-week follow-up period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nantes	Nantes		France	44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator: Mauricette MICHALLET, PU PH, CHU de Lyon
Principal Investigator: Sabine FURST, PH, Institut Paoli et Calmette (Marseille)
Principal Investigator: Valérie COITEUX, PU PH, CHRU de Lille
Principal Investigator: Stéphane VIGOUROUX, PH, University Hospital, Bordeaux
Principal Investigator: Mohamad MOHTY, PU PH, AP-HP Saint Antoine
Principal Investigator: Thomas GASTINNE, PH, CHU de Nantes