Post Transplant in Immunosuppression w/CSA & Mycophenolate MofetilPhase 1NCT00531635
Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil
A Phase 1 study testing Mycophenolate Mofetil in people with Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Induction of mixed hemopoietic chimerism in patients using Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA \& Mycophenolate Mofetil Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil
- What is being tested?
- Mycophenolate Mofetil
- How many people
- 350 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jul 2002to Jun 2012
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients receiving Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA \& Mycophenolate Mofetil.
Who cannot join
- Uncontrolled major medical illnesses
Trial locations and contacts
1 site in 1 country.
Ed Colcol contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
KFSH&RC
Riyadh, 11211
Mahmoud Aljurf, MD, 966-1-4647272 ext. 24586
Ed Colcol, 966-1-4647272 ext. 38015, colcol@kfshrc.edu.sa
About this study
Induction of mixed hemopoietic chimerism in patients using Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA \& Mycophenolate Mofetil
- Being tested
- Mycophenolate Mofetil
- Keywords
- Mixed hemopoietic chimerism, Fludarabine, TBI, PBSC, immunosuppression, Mycophenolate Mofetil
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of Mixed Hemopoietic Chimerism in Patients Using Mycophenolate Mofetil
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Measured: 2001-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startJul 2002
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Transplant in Immunosuppression w/CSA & Mycophenolate MofetilStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Aljurf, MD, Principal investigator, KFSH&RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531635
- Sponsor's protocol ID
- RAC#2001-051
- Status last verified
- Dec 2011
- First submitted
- 17 Sep 2007
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Mixed Hemopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil
- ClinicalTrials.gov ID
- NCT00531635
- Acronym / sponsor ID
- RAC#2001-051
- Keywords
- Mixed hemopoietic chimerism, Fludarabine, TBI, PBSC, immunosuppression, Mycophenolate Mofetil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Jul 2002
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 19 Sep 2007 (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.
Induction of mixed hemopoietic chimerism in patients using Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA \& Mycophenolate Mofetil
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving Fludarabine, Low Dose TBI, PBSC Infusion and post transplant in immunosuppression w/CSA \& Mycophenolate Mofetil.
Key exclusion criteria (1 listed)
- Uncontrolled major medical illnesses
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 |
|---|---|---|
| Mycophenolate MofetilInduction of Mixed Hemopoietic Chimerism in Patients Using Mycophenolate Mofetil | Drug | – |
Primary outcome
Efficacy
Time frame: 2001-2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
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.
Ed Colcol contact
Mahmoud Aljurf, MD principal investigator
KFSH&RC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mycophenolate Mofetil in people with Post Transplant in Immunosuppression w/CSA & Mycophenolate Mofetil, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Dec 2011. 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 Saudi Arabia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud AlJurf, MD (966-1-4647272 ext. 24586, maljurf@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 2001-2012). 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 13 Dec 2011.