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Tabelecleucel for EBV Associated Diseases
Study Summary
This trial will test a new treatment for diseases caused by the Epstein-Barr virus.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My cancer can be measured by tests in my body or brain.I require medication to maintain my blood pressure or need help to breathe.I have a severe reaction from a transplant, known as GvHD.I am 16 or older and can care for myself but not fully active. Or, I am under 16 and mostly active.I haven't had certain cell therapies or treatments that affect immune cells within the last 8 weeks.My lymphoma is not Burkitt, T-cell (except HLH), NK/T-cell, Hodgkin, or transformed.I am scheduled for a definitive treatment like a stem cell transplant or gene therapy for my primary immunodeficiency.I have had a bone marrow or organ transplant.I haven't taken any experimental drugs or cancer treatments recently.My organs work well, unless the issue is caused by my EBV-related disease.I have followed the required waiting period after my last treatment before joining.I do not have any serious ongoing infections needing strong medication.I am unwilling to follow the study's birth control requirements.I am not pregnant or breastfeeding.I am currently taking daily steroids higher than 0.5 mg/kg, methotrexate, or undergoing extracorporeal photopheresis.My cancer affects both my body and brain or just my brain.I have been diagnosed with an EBV+ disorder.I am 16 or older and can care for myself but not fully active; or I am under 16 and mostly active.
- Group 1: EBV+ CNS PTLD
- Group 2: EBV+ PTLD (inappropriate for first-line therapy or CD20-negative)
- Group 3: EBV+ sarcoma, including LMS, or smooth muscle tumors
- Group 4: EBV+ AID LPD
- Group 5: EBV+ PID LPD
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA granted its stamp of approval to Tabelecleucel?
"Tabelecleucel's safety was measured at a level 2, meaning that while there is data to suggest its safety, the efficacy of this medication has yet to be determined."
What is the capacity of participants for this experiment?
"Affirmative. Clinicaltrials.gov confirms that this study, which was initially published on July 14th 2021 is actively enrolling eligible patients. The study plans to recruit 228 individuals from 23 distinct sites."
What is the scope of locations participating in this trial?
"Currently, this clinical trial is running out of 23 locations. Not only are there sites in Los Angeles, Palo Alto and Minneapolis but also 20 other cities. To reduce the strain on patients participating, it could be beneficial to choose a nearby site for convenience."
Are there any openings to join this experiment currently?
"Clinicaltrials.gov confirms that this medical trial is actively recruiting, with the initial post going live on July 14th 2021 and a recent update posted on November 9th 2022."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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