NCT00413439

Brief Summary

Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections. The study investigates the safety and tolerability of two different dosages, the efficacy in prevention of fungal diseases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

December 18, 2006

Last Update Submit

May 9, 2023

Conditions

Acute Myeloid Leukemia

Keywords

IsavuconazoleBAL8557ASP9766chemotherapyprophylaxissystemic fungal infection

Outcome Measures

Primary Outcomes (1)

  • Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs)

    Up to Day 28

Secondary Outcomes (2)

  • Efficacy assessed by the frequency of invasive fungal infections

    Up to Day 28

  • Pharmacokinetics: drug plasma levels

    Up to Day 28

Study Arms (2)

Low dose isavuconazole intravenous solution

EXPERIMENTAL
Drug: Isavuconazole

High dose isavuconazole intravenous solution or oral capsules

EXPERIMENTAL
Drug: Isavuconazole

Interventions

IsavuconazoleDRUG

Intravenous solution or oral capsules

Also known as: ASP9766, BAL8557
High dose isavuconazole intravenous solution or oral capsulesLow dose isavuconazole intravenous solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of acute myeloid leukemia
  • patients entering first induction treatment; or subsequent chemotherapy if no prior invasive fungal infection was observed
  • expected to be neutropenic for \>9 and \<28 days after enrollment
  • women of childbearing potential must have a negative pregnancy test

You may not qualify if:

  • patients who received any systemic antifungal therapy for more than 72 hours prior to first administration of study medication. Topical polyenes or nystatin are acceptable but should be discontinued during the study
  • patients who received systemic antifungal therapy for proven or probable fungal infection in the last 12 months
  • patients with fever defined as central body temperature of \> 38°C
  • known hypersensitivity to azoles or any component of the study medication
  • concomitant use of rifampicin, rifabutin, ergots alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine, and carbamazepine
  • hepatic or severe renal dysfunction
  • patients with a medical history of oliguria unresponsive to fluid challenge
  • patients with a concomitant medical condition that may be an unacceptable additional risk to the patient should he/she participate in the study
  • treatment with any investigational drug within 30 days prior to the first administration of study medication except open label chemotherapy protocols
  • suspected other or additional cause for neutropenia or immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Bremen, Germany

Location

University Cologne

Cologne, 50937, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Mainz, Germany

Location

Related Publications (1)

  • Cornely OA, Bohme A, Schmitt-Hoffmann A, Ullmann AJ. Safety and pharmacokinetics of isavuconazole as antifungal prophylaxis in acute myeloid leukemia patients with neutropenia: results of a phase 2, dose escalation study. Antimicrob Agents Chemother. 2015 Apr;59(4):2078-85. doi: 10.1128/AAC.04569-14. Epub 2015 Jan 26.

    PMID: 25624327DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

isavuconazole

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Oliver Cornely, MD

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2006

First Posted

December 19, 2006

Study Start

May 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

DE(4)