A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
This study is a Phase 3 trial looking into a new treatment called tabelecleucel. It's for people who have developed a rare but serious condition called Epstein-Barr Virus-associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD). This condition sometimes occurs after receiving an organ transplant (like a kidney, liver, or heart) or a stem cell transplant. The study is specifically for patients whose EBV+ PTLD has not responded to previous treatments like rituximab, or rituximab combined with chemotherapy. The main goals are to find out if tabelecleucel can help treat this condition and if it is safe to use. Researchers hope this new medicine could offer a vital option for patients struggling with EBV+ PTLD.
At a glance
What is this study about?
This study is a clinical trial, which is a type of research study designed to test new medical treatments in people. The treatment being tested here is called tabelecleucel. It's for a condition known as Epstein-Barr Virus-associated Post-Transplant Lymphoproliferative Disease, or EBV+ PTLD for short. This is a rare but serious complication that can sometimes happen after a patient has received a transplant, either a solid organ transplant (like a kidney, liver, or heart) or a stem cell transplant.
After a transplant, patients need medicines to stop their body from rejecting the new organ or cells. These medicines can sometimes weaken the immune system, which then makes it easier for viruses like the Epstein-Barr Virus (the same virus that causes glandular fever) to become active and lead to EBV+ PTLD. This condition involves the uncontrolled growth of certain immune cells, which is why it's called a 'lymphoproliferative disease'.
The study is specifically focusing on patients whose EBV+ PTLD hasn't gotten better with standard treatments, such as rituximab, or rituximab combined with chemotherapy. Researchers want to see if tabelecleucel can effectively treat this condition and whether it's safe for patients. This is a 'Phase 3' study, which means it's one of the final steps before a new medicine might be approved for wider use, if found to be safe and effective.
Key takeaways
- This study tests a new medicine for EBV+ PTLD.
- It's for people who have had a transplant and previous treatments haven't worked.
- The medicine (tabelecleucel) is given through an IV.
- Participation involves treatment cycles and long-term follow-up.
- It's a Phase 3 study, a later stage of clinical research.
- All ages are welcome, provided they meet other criteria.
Who may be eligible?
This study is looking for both adults and children who have developed EBV+ PTLD. You would be considered if you have had an organ transplant (like a kidney, liver, heart, lung, or pancreas) or a stem cell transplant. A doctor would need to have officially diagnosed you with EBV+ PTLD based on a biopsy.
Crucially, your EBV+ PTLD must not have responded to previous treatments, such as rituximab alone, or rituximab combined with chemotherapy. Also, imaging tests (like a PET scan or MRI) must show that your disease can be measured and is active. You also need to be generally well enough to take part, as assessed by a doctor, and have certain blood test results within acceptable ranges. The particular type of tabelecleucel needed for you must also be available.
- Have you had an organ or stem cell transplant?
- Have you been diagnosed with EBV+ PTLD by a biopsy?
- Has your EBV+ PTLD not improved with rituximab-based treatments?
- Do you have active disease that can be seen on scans?
- Are you generally well enough for a clinical study?
- Do your doctors think you meet the other specific study requirements?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, the medicine, tabelecleucel, will be given into your vein (intravenously). This will happen on three separate days (Day 1, Day 8, and Day 15) within a 5-week period, which is called a 'cycle'. You will then be observed for the rest of that cycle.
Treatment will continue for as long as it's helping you, or until unacceptable side effects occur, or if another treatment is needed, or if the medicine doesn't seem to be working. After your treatment ends, you'll have follow-up visits. For some participants, this follow-up could last up to 5 years, checking on your health and disease status. For others joining later, follow-up will be every 3 months for up to 12 months, or 12 months from when your disease first responded if you showed improvement.
Potential risks and benefits
Locations (71)
- City of Hope (Adults and Pediatrics)Duarte, United States· Completed
- University of California San Diego Moores Cancer Center (Adults only)La Jolla, United States· Completed
- Loma Linda University Medical Center (Adults only)Loma Linda, United States· Recruiting
- Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)Los Angeles, United States· Recruiting
- UCLA Medical Center (Adults and Pediatrics)Los Angeles, United States· Completed
- University of California Davis Comprehensive Cancer Center (Adults only)Sacramento, United States· Completed
- Yale University (Adults and Pediatrics)New Haven, United States· Completed
- MedStar Georgetown University Hospital (Adults and Pediatrics)Washington D.C., United States· Recruiting
- University of Florida (Adults and Pediatrics)Gainesville, United States· Completed
- University of Miami/Jackson Memorial Hospital (Adults only)Miami, United States· Recruiting
- Winship Cancer Institute (Adults only)Atlanta, United States· Completed
- Arthur M. Blank Hospital (Pediatrics)Atlanta, United States· Recruiting
+59 more sites — see the official record for the full list.
Common questions
What is EBV+ PTLD?
EBV+ PTLD is a condition where certain immune cells grow too much, caused by the Epstein-Barr Virus, and can happen after an organ or stem cell transplant.
What is tabelecleucel?
Tabelecleucel is an experimental medicine being tested in this study to treat EBV+ PTLD.
Who is this study for?
This study is for transplant patients with EBV+ PTLD that hasn't improved with rituximab treatment, or rituximab and chemotherapy.
How is the medicine given?
Tabelecleucel is given as an infusion into a vein on specific days over a 5-week treatment cycle.
How long will I be followed up?
Follow-up can range from 12 months to up to 5 years, depending on when you joined the study and your response to treatment.
How to find out more
Anke Friedetzky
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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