- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00063648
Detection and Cytotoxic T Lymphocyte Therapy of Post-Transplant Lymphoproliferative Disorder After Liver Transplant
January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Despite advances in medical and gene therapy, orthotopic liver transplantation remains the only definitive therapeutic option for children with end-stage liver disease.
Recent advances in pre-, intra-, and early post-transplant care have resulted in a dramatic improvement in survival of the pediatric liver transplant patient.
The broad long-range goal of our research program is directed at enhancing the patient's long-term survival.
Our primary focus relates to obligate life-long immunosuppression, with its inherent complications including severe infection and development of cancer.
These two complications come together in a single disease, Epstein-Barr Virus (EBV)- associated post-transplant lymphoproliferative disorder (PTLD).
EBV, a latent human lymphotrophic herpes virus infects and immortalizes B cells.
Primary infection usually occurs via salivary exchange and results in a mild, self-limited illness followed by life-long EBV-specific T cell controlled EBV latency.
T cell-based immunosuppression prevents allograft rejection, however, it also suppresses cytotoxic T lymphocyte (CTL) function, generating an environment in which EBV-infected cells can proliferate.
Patients receiving life-long T cell-based immunosuppression have an increased risk of developing PTLD due to their inability to produce normal immunoregulatory responses.
This disease is particularly devastating to the pediatric patient as its incidence is at least 4-fold greater than in the adult liver transplant patient population.
In fact, PTLD is the number one cause of death following pediatric liver transplantation.
At this time, there is no definitive method of prospectively detecting, diagnosing, or treating PTLD, and current treatment protocols place the liver allograft and patient at risk.
Therefore, a diagnostic tool that is both sensitive and specific, and a treatment strategy with low toxicity are greatly needed to decrease the morbidity and mortality suffered by the pediatric liver transplant patient with PTLD.
Our proposed studies will support our hypothesis that the combination of a persistently elevated EBV load in the setting of a diminished immune response to EBV will be an early risk indicator associated with PTLD development, and that pre-emptive treatment utilizing autologous adoptive EBV-specific CTL immunotherapy will provide a low toxicity treatment option.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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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
1 month to 21 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Pediatric patients s/p orthotopic liver transplantation
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
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
May 1, 2002
Study Completion
December 1, 2007
Study Registration Dates
First Submitted
July 1, 2003
First Submitted That Met QC Criteria
July 2, 2003
First Posted (Estimate)
July 3, 2003
Study Record Updates
Last Update Posted (Estimate)
January 13, 2010
Last Update Submitted That Met QC Criteria
January 12, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTLD (completed)
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 Lymphoproliferative Disorders
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A.O. Ospedale Papa Giovanni XXIIICompletedPost-transplant Lymphoproliferative Disease (PTLD) | Non BurkittItaly
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Becton, Dickinson and CompanyCompletedChronic Lymphoproliferative Diseases (CLPD)United States, Switzerland, Spain, United Kingdom, Portugal
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Geron CorporationCompletedChronic Lymphoproliferative DiseasesUnited States
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Diako Ev. Diakonie-Krankenhaus gemeinnützige GmbHCompletedPosttransplant Lymphoproliferative DisorderGermany
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Becton, Dickinson and CompanyRecruitingChronic Lymphoproliferative Diseases (CLPD)Switzerland, United States, Portugal, Spain
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)TerminatedLymphoproliferative DisorderUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedRecurrent Lymphoproliferative Disorder | Refractory Lymphoproliferative DisorderUnited States
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Charite University, Berlin, GermanyTerminatedPost-transplantation Lymphoproliferative DisorderAustralia, France, Germany, Sweden
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Hospices Civils de LyonCompleted
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Timothy VoorheesRecruitingPolymorphic Post-Transplant Lymphoproliferative Disorder | Monomorphic B-Cell Post-Transplant Lymphoproliferative DisorderUnited States
Clinical Trials on EBV-specific autologous CTL
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Baylor College of MedicineThe Methodist Hospital Research Institute; Center for Cell and Gene Therapy...Active, not recruitingHodgkin's Lymphoma | Non-Hodgkin's LymphomaUnited States
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Nantes University HospitalTerminatedSerologically Active Adult Systemic Lupus ErythematosusFrance
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Nantes University HospitalRecruiting
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Nantes University HospitalUnknown
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Baylor College of MedicineThe Methodist Hospital Research Institute; Center for Cell and Gene Therapy...CompletedT-Lymphocytes in Treating Patients With Epstein-Barr Virus-Positive Nasopharyngeal Cancer, NPC (NPC)Head and Neck CancerUnited States
-
Baylor College of MedicineCenter for Cell and Gene Therapy, Baylor College of MedicineActive, not recruiting
-
University College, Londonbluebird bioActive, not recruitingPost-transplant Lymphoproliferative Disease | Transplant-Related Hematologic MalignancyUnited Kingdom
-
Baylor College of MedicineThe Methodist Hospital Research Institute; Center for Cell and Gene Therapy...TerminatedBrain Cancer | Glioblastoma Multiforme | GBMUnited States
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University College, LondonDeutsche Krebshilfe e.V., Bonn (Germany); European Union; The Leukemia and Lymphoma... and other collaboratorsTerminatedAcute Lymphoblastic LeukemiaUnited Kingdom, Germany
-
Shixiu WuUnknownDigestive System Diseases | Esophageal Neoplasms | Esophageal DiseasesChina