Actively Recruiting

All Genders
NCT05711732

Busulfan Sample Collection Study

Led by Saladax Biomedical, Inc. · Updated on 2025-04-03

150

Participants Needed

2

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Busulfan Sample Collection Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric and adult female or male subjects
  • Currently receiving intravenous busulfan treatment for diagnosed malignant hematologic or non-malignant disease
  • Adults must be able to understand and provide written informed consent as approved by an Institutional Review Board (IRB)
  • Participants under 18 years must provide written assent with legal guardian's IRB-approved consent prior to study procedures
Not Eligible

You will not qualify if you...

  • Unwilling or unable to follow protocol requirements or to give written informed consent
  • Receiving oral busulfan treatment (e.g., Myleran�)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

2

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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