LeukemiaNCT00764829
Blood Samples to Evaluate Biomarkers of Donor Chimerism
An observational study of Leukemia and Hodgkins Disease, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
We are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. We will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Hodgkins Disease, Non-hodgkins Lymphoma
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Feb 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hematopoietic stem cell transplant patients receiving fludarabine and mycophenolate mofetil.
Who may be able to join
- Diagnosed with a hematologic disease or malignancy
- Scheduled to receive nonablative conditioning with fludarabine and total body irradiation
- Donor is well-matched by high resolution DNA techniques.
- Scheduled to receive postgrafting immunosuppression of oral MMF (CellCept) and an oral calcineurin inhibitor.
- Age >18 years at the time of enrollment.
Who cannot join
- -Diagnosed with an immunodeficiency disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
We are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. We will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body.
- Keywords
- hematopoietic stem cell transplantation, fludarabine, mycophenolate mofetil, mycophenolic acid, biomarkers
- Medical subject headings
- Leukemia, Hodgkin Disease, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor T-cell chimerism
Measured: Day 28 post-transplant
Secondary outcomes (1)
Exposure to fludarabine and mycophenolate mofetil and their breakdown products.
Measured: Before and after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Jeannine S McCune, PharmD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764829
- Sponsor's protocol ID
- FHCRC - 1980.00
- Other IDs
- R01HL091744, IR-5957
- Status last verified
- Feb 2012
- First submitted
- 30 Sep 2008
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Samples to Evaluate Biomarkers of Donor Chimerism
- ClinicalTrials.gov ID
- NCT00764829
- Acronym / sponsor ID
- FHCRC - 1980.00
- Keywords
- hematopoietic stem cell transplantation, fludarabine, mycophenolate mofetil, mycophenolic acid, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Oct 2008 (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.
We are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. We will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hematopoietic stem cell transplant patients receiving fludarabine and mycophenolate mofetil.
Key inclusion criteria (5 listed)
- Diagnosed with a hematologic disease or malignancy
- Scheduled to receive nonablative conditioning with fludarabine and total body irradiation
- Donor is well-matched by high resolution DNA techniques.
- Scheduled to receive postgrafting immunosuppression of oral MMF (CellCept) and an oral calcineurin inhibitor.
- Age >18 years at the time of enrollment.
Key exclusion criteria (1 listed)
- -Diagnosed with an immunodeficiency disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Donor T-cell chimerism
Time frame: Day 28 post-transplant
1 secondary outcome
Exposure to fludarabine and mycophenolate mofetil and their breakdown products.
Time frame: Before and after transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
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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.
Jeannine S McCune, PharmD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Hodgkins Disease, run by Fred Hutchinson Cancer Center at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 15 Feb 2012. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Donor T-cell chimerism (time frame: Day 28 post-transplant). 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 15 Feb 2012.