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NCT05711732 · ClinicalTrials.gov registry record

Busulfan Sample Collection Study

A clinical trial of Subjects Treated With Busulfan, sponsored by Saladax Biomedical.

Recruiting
Registry status
150
Enrollment target
2
Study locations

NCT05711732: Recruiting study of Subjects Treated With Busulfan, sponsored by Saladax Biomedical.

NCT05711732 is a study of Subjects Treated With Busulfan that is actively recruiting participants, run by Saladax Biomedical. The registered enrollment target is 150 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05711732, a study of Subjects Treated With Busulfan, is actively recruiting participants, sponsored by Saladax Biomedical.

RECRUITING
Registry status
150 participants
Enrollment target
2
Study locations

Study Summary

Busulfan (Busulfex®) is an alkylating drug used as a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation. Busulfan has wide inter- and intra-patient pharmacokinetic variability resulting in variable exposure leading to increased risk of toxicities or sub-optimal treatment outcomes. Therapeutic drug monitoring of busulfan using patient plasma samples would benefit clinicians by providing the ability to personalize the dose to achieve a target busulfan exposure.

Primary Outcome

The samples being collected according to the protocol, SBI-BSI-001, will be used to compare the quantitate determination of BSF in patient samples based on the immunoassay vs. LC-MS/MS methods .

Interventions

  • DIAGNOSTIC_TEST MyCare Oncology Busulfan Assay Kit

Study Locations (2)

Illinois

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago

Texas

  • The University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-02-08
Est. Completion 2026-01-31
Saladax Biomedical

4 total trials

What NCT05711732 shows while recruiting

NCT05711732 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.

The record links to 1 condition, with Subjects Treated With Busulfan appearing as the primary indexed condition, and to 1 intervention - of which MyCare Oncology Busulfan Assay Kit is the first listed.

NCT05711732 reports a single indexed study location in Illinois, Texas.

Frequently Asked Questions

What is clinical trial NCT05711732 about?

NCT05711732 is a clinical study titled "Busulfan Sample Collection Study". Busulfan (Busulfex®) is an alkylating drug used as a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation. Busulfan has wide inter- and intra-patient pharmacokinetic variability resulting in variable exposure leading to increased risk of toxicities or sub-optimal treatmen...

What is the current status of trial NCT05711732?

This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2024-02-08. Estimated completion is 2026-01-31.

What conditions does trial NCT05711732 study?

This clinical trial studies the following conditions: Subjects Treated With Busulfan.

What interventions are being tested in trial NCT05711732?

The interventions under investigation include: MyCare Oncology Busulfan Assay Kit (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05711732?

This trial is sponsored by Saladax Biomedical, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05711732 being conducted?

This trial has 2 study locations across Illinois, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05711732, the US trial registry maintained by the National Library of Medicine. NCT05711732 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.