NCT02291965

Brief Summary

Specific Aim 1: To determine whether endogenous metabolomics-based biomarkers obtained before IV BU administration can predict IV BU clearance. Specific Aim 2: To characterize IV BU metabolism by metabolomics. Specific Aim 3: To identify covariates influencing IV BU pharmacokinetics.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2024

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

4.5 years

First QC Date

November 4, 2014

Last Update Submit

February 27, 2025

Conditions

LeukemiaLymphomaMultiple MyelomaImmunodeficiencyMyelodysplastic Syndrome

Keywords

hematopoietic cell transplant

Outcome Measures

Primary Outcomes (1)

  • Busulfan clearance

    24 hours after start of busulfan

Secondary Outcomes (1)

  • Overall survival

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving targeted IV busulfan as part of conditioning for a hematopoietic stem cell transplant

You may qualify if:

  • Scheduled to receive targeted intravenous busulfan (any dose, any number of doses, any dosing frequency) as part of their hematopoietic stem cell transplant conditioning;
  • Weight \> 21kg.

You may not qualify if:

  • Unable to read English;
  • Female patients who are pregnant or breastfeeding;
  • Life expectancy severely limited by diseases other than malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples from metabolomic and/or pharmacokinetic analysis.

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaImmunologic Deficiency SyndromesMyelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow Diseases

Study Officials

  • Jeannine S. McCune, PharmD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 17, 2014

Study Start

November 1, 2014

Primary Completion

April 20, 2019

Study Completion

October 7, 2024

Last Updated

March 3, 2025

Record last verified: 2025-02

Locations

US(1)