- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05711732
Busulfan Sample Collection Study
January 25, 2023 updated by: Saladax Biomedical, Inc.
Collection of Plasma Samples Using Sodium Heparin From Subjects Undergoing Intravenous Busulfan Treatment
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This protocol is sponsored by Saladax Biomedical, Inc (SBI).
The protocol involves the use of sodium heparin plasma sample collected from human subjects receiving intravenous busulfan treatment for the use in the development of a diagnostic test for this drug.
A subset of 10 enrolled subject samples will be tested on site using an automated immunoassay MyCareTM Oncology Busulfan Assay Kit manufactured by SBI.
Study Type
Observational
Enrollment (Anticipated)
150
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Up to 150 unique subjects across participating sites consisting of males and females who meet the protocol Inclusion/ Exclusion criteria as described above.
Multiple (3 to 12) plasma samples by venous draw will be collected from each subject for a single day of busulfan dosing.
Sample collection timing used to inform dose calculation shall be performed per the site standard of clinical care for patients prescribed busulfan.
Description
Inclusion Criteria:
- Pediatric and adult female or male subjects;
- Current treatment with intravenous busulfan with documentation of diagnosed malignant hematologic or non-malignant disease condition requiring treatment;
- Adult participants must be capable of understanding and providing written informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study-specific procedures. Participants less than 18 years old must provide written assent with appropriate consent provided by legal guardian, who must be capable of understanding and providing informed consent, per Institutional Review Board (IRB) procedures, prior to the initiation of any screening or study-specific procedures.
Exclusion Criteria:
- Unwilling or unable to follow protocol requirements or to give written informed consent;
- Patients receiving oral busulfan (e.g., Myleran®) treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Method Comparison Study
Time Frame: Sample collection to take place over 1 year. Samples to be analyzed monthly.
|
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 .
|
Sample collection to take place over 1 year. Samples to be analyzed monthly.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
May 15, 2023
Primary Completion (ANTICIPATED)
May 15, 2024
Study Completion (ANTICIPATED)
June 15, 2024
Study Registration Dates
First Submitted
January 25, 2023
First Submitted That Met QC Criteria
January 25, 2023
First Posted (ACTUAL)
February 3, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 3, 2023
Last Update Submitted That Met QC Criteria
January 25, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBI-BSF-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subjects Treated With Busulfan
-
University Hospital, GenevaEuropean Society for Blood and Marrow TransplantationRecruitingChildren Who Receive a Stem Cell Transplantation With Busulfan IVCanada, France, Switzerland
-
Universitaire Ziekenhuizen KU LeuvenCompletedPatients Treated With VoriconazoleBelgium
-
AstraZenecaEli Lilly and Company; i3 Drug SafetyCompletedType 2 Diabetes (Treated With Exenatide or Other Oral Antidiabetic Therapies) | Healthy Subjects (Treated With no Diabetes Therapies)United States
-
A.T. Still University of Health SciencesAmerican Osteopathic AssociationCompleted
-
Sound Surgical Technologies, LLC.CompletedPatients Treated With VaserShape MC1United States
-
Institut BergoniéInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedCancer Treated With Immune-checkpoint InhibitorsFrance
-
Massachusetts General HospitalRecruitingPediatric Patients Treated With Radiation TherapyUnited States
-
Boston Scientific CorporationActive, not recruitingChinese Patients Treated With Agent DCBTaiwan, Hong Kong, Singapore
-
AstraZenecaCompletedAll Patients Treated With the ProductJapan
-
Yuhan CorporationRecruitingAtopic Healthy Subjects | Adult Subjects With Mild Allergic DiseasesKorea, Republic of
Clinical Trials on MyCare Oncology Busulfan Assay Kit
-
Becton, Dickinson and CompanyActive, not recruiting
-
Chinese University of Hong KongRecruiting
-
Yonsei UniversityCompleted
-
IRCCS Policlinico S. MatteoCompleted
-
Qianfoshan HospitalNot yet recruitingCancer | HIV Seropositivity | Blood Disease
-
Hospices Civils de LyonCompletedPatients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal ExaminationFrance
-
Hillel Yaffe Medical CenterRecruiting
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingBRCA-Associated Breast CarcinomaItaly
-
Mayo ClinicEnrolling by invitation