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MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients

Primary Purpose

Fungal Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Voriconazole

About this trial

This is an interventional treatment trial for Fungal Infection focused on measuring stem cell transplant, hematopoietic stem cell transplant, fungal infection, voriconazole, pediatric

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Any patient undergoing allogeneic hematopoietic stem cell transplantation (either 1st or subsequent)
Age ≤ 21 years
Adequate organ function within 14 days of enrollment, i.e. Creatinine: < 1.5 x ULN and Hepatic: ALT, AST and total bilirubin < 3 x ULN
Requires voriconazole to prevent or treat invasive fungal infection after undergoing stem cell transplantation

Exclusion Criteria:

Has received voriconazole within 5 days prior to starting study therapy
History of hypersensitivity or severe intolerance to azoles
History, or current evidence, of cardiac arrhythmias defined as QTc ≥ 480 mm/sec
Receiving the following drugs and cannot be discontinued at least 24 hours before starting therapy: pimozide, quinidine, astemizole, ergot alkaloids.
Received one or more of the following drugs within 14 days prior to starting study, as they are potent inducers of hepatic microsomal enzymes: rifampin, rifabutin, carbamazepine, phenytoin, nevirapine, long-acting barbiturates.
Received sirolimus within the 14 days prior to starting study as voriconazole is a potent inhibitor of sirolimus metabolism
Receiving or anticipated need for methadone as co-administration with voriconazole potentially increases methadone exposure

Sites / Locations

University of Minnesota Medical Center, Fairview

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Voriconazole

Arm Description

Outcomes

Primary Outcome Measures

Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups

Secondary Outcome Measures

Correlation of initial dose of voriconazole with voriconazole blood concentration in 3 different pediatric age groups

Correlation of voriconazole dose with elevations to 5 times the upper limit of normal in liver enzymes

Incidence of fungal infection

Full Information

NCT ID

NCT02227797

First Posted

August 26, 2014

Last Updated

April 26, 2019

Sponsor

Masonic Cancer Center, University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT02227797

Brief Title

MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients

Official Title

MT2013-37R: Voriconazole Therapeutic Drug Monitoring in Pediatric Hematopoietic Stem Cell Transplant Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

January 19, 2015 (Actual)

Primary Completion Date

September 8, 2017 (Actual)

Study Completion Date

March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary purpose of this study is to identify the optimal dose of voriconazole, an anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level is one level that provides a good blood level (concentration) of voriconazole without too much toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fungal Infection

Keywords

stem cell transplant, hematopoietic stem cell transplant, fungal infection, voriconazole, pediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Voriconazole

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Voriconazole

Intervention Description

6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients

Primary Outcome Measure Information:

Title

Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups

Time Frame

Seven days after starting voriconazole

Secondary Outcome Measure Information:

Title

Correlation of initial dose of voriconazole with voriconazole blood concentration in 3 different pediatric age groups

Time Frame

After starting voriconazole: Day 5, between Days 12-15, between Days 19-22

Title

Correlation of voriconazole dose with elevations to 5 times the upper limit of normal in liver enzymes

Time Frame

After starting voriconazole: Twice a week Days 1-30 and 1 week after the last dose of voriconazole ~ Day 35-42

Title

Incidence of fungal infection

Time Frame

6-month period after transplant

10. Eligibility

Sex

All

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Any patient undergoing allogeneic hematopoietic stem cell transplantation (either 1st or subsequent) Age ≤ 21 years Adequate organ function within 14 days of enrollment, i.e. Creatinine: < 1.5 x ULN and Hepatic: ALT, AST and total bilirubin < 3 x ULN Requires voriconazole to prevent or treat invasive fungal infection after undergoing stem cell transplantation Exclusion Criteria: Has received voriconazole within 5 days prior to starting study therapy History of hypersensitivity or severe intolerance to azoles History, or current evidence, of cardiac arrhythmias defined as QTc ≥ 480 mm/sec Receiving the following drugs and cannot be discontinued at least 24 hours before starting therapy: pimozide, quinidine, astemizole, ergot alkaloids. Received one or more of the following drugs within 14 days prior to starting study, as they are potent inducers of hepatic microsomal enzymes: rifampin, rifabutin, carbamazepine, phenytoin, nevirapine, long-acting barbiturates. Received sirolimus within the 14 days prior to starting study as voriconazole is a potent inhibitor of sirolimus metabolism Receiving or anticipated need for methadone as co-administration with voriconazole potentially increases methadone exposure

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angela Smith, M.D.

Organizational Affiliation

Masonic Cancer Center, University of Minnesota

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pui-Yang Iroh Tam, M.D.

Organizational Affiliation

Masonic Cancer Center, Univeristy of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota Medical Center, Fairview

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34970774

Citation

Takahashi T, Jaber MM, Smith AR, Jacobson PA, Fisher J, Kirstein MN. Predictive Value of C-Reactive Protein and Albumin for Temporal Within-Individual Pharmacokinetic Variability of Voriconazole in Pediatric Patients Undergoing Hematopoietic Cell Transplantation. J Clin Pharmacol. 2022 Jul;62(7):855-862. doi: 10.1002/jcph.2024. Epub 2022 Feb 19.

Results Reference

derived

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MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients

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