Busulfan Pharmacokinetic AnalysisPhase 4NCT01071486
Busulfan Pharmacokinetic Analysis and GST Polymorphism in Adults Undergoing Hematological Stem Cell Transplantation
A Phase 4 study testing Hematological Stem Cell Transplantation in people with Busulfan Pharmacokinetic Analysis and GST Genetic Polymorphism, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be investigated using real time PCR. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Busulfan Pharmacokinetic Analysis, GST Genetic Polymorphism
- What is being tested?
- Hematological Stem Cell Transplantation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant or Benign Diseases who need hematological stem cell transplantation as part of their treatment
- Busulfan should be part of the preparative protocol
Who cannot join
- Known sensitivity or allergy to Busulfan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Busulfan Pharmacokinetic Analysis and Glutathione S-transferase (GST)Genetic Polymorphism (A1,T1,M1,P1)in Adults Undergoing Hematological Bone Marrow Transplantation (HSCT).
Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be investigated using real time PCR. A correlation between pharmacokinetic parameters and patients polymorphism will be performed using known statistical technics for comparison. The aims of this study are, to correlate the demographic data, clinical presentation, clinical outcomes of the included individuals, the BU kinetics and the GST polymorphism and to establish an outcome "map" for those who receive HSCT for their primary disease.
- Being tested
- Hematological Stem Cell Transplantation
- Keywords
- Busulfan, Glutathione S-transferase, Genetic polymorphism, HVOD, GVHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematological Stem Cell TransplantationDrug
Oral or Intravenous Busulfan as part of the preparative protocol for transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Veno-Occlusive Disease, Graft versus host disease
Measured: every week after HSCT up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startAug 2009
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Busulfan Pharmacokinetic AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Israel Cancer Association
- Responsible party
- Principal investigator, N_Krivoy, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071486
- Sponsor's protocol ID
- BU-AdultPK/PGx1
- Status last verified
- Nov 2015
- First submitted
- 18 Feb 2010
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Busulfan Pharmacokinetic Analysis and Glutathione S-transferase (GST)Genetic Polymorphism (A1,T1,M1,P1)in Adults Undergoing Hematological Bone Marrow Transplantation (HSCT).
- ClinicalTrials.gov ID
- NCT01071486
- Acronym / sponsor ID
- BU-AdultPK/PGx1
- Keywords
- Busulfan, Glutathione S-transferase, Genetic polymorphism, HVOD, GVHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Israel Cancer Association
- Study start
- Aug 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be investigated using real time PCR. A correlation between pharmacokinetic parameters and patients polymorphism will be performed using known statistical technics for comparison. The aims of this study are, to correlate the demographic data, clinical presentation, clinical outcomes of the included individuals, the BU kinetics and the GST polymorphism and to establish an outcome "map" for those who receive HSCT for their primary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Malignant or Benign Diseases who need hematological stem cell transplantation as part of their treatment
- Busulfan should be part of the preparative protocol
Key exclusion criteria (1 listed)
- Known sensitivity or allergy to Busulfan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematological Stem Cell TransplantationOral or Intravenous Busulfan as part of the preparative protocol for transplantation | Drug | – |
Primary outcome
Hepatic Veno-Occlusive Disease, Graft versus host disease
Time frame: every week after HSCT up to 6 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
Related trials for Busulfan Pharmacokinetic Analysis
Not yet recruitingPhase 1
26DT052; Scaling Busulfan Dose to Body Surface Area in Children
Busulfan Pharmacokinetic Analysis, Busulfan Dosing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hematological Stem Cell Transplantation in people with Busulfan Pharmacokinetic Analysis and GST Genetic Polymorphism, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic Veno-Occlusive Disease, Graft versus host disease (time frame: every week after HSCT up to 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.