Tabelecleucel for Epstein-Barr Virus-Related Lymphoma

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

Recruiting Phase 3 Interventional Study
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) Solid Organ Transplant Complications Lymphoproliferative Disorders Allogeneic Hematopoietic Cell Transplant Stem Cell Transplant Complications
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
115 (estimated)
Sponsor
Pierre Fabre Medicament · Industry
Who this trial is looking for

This trial is looking for individuals who have had a solid organ or stem cell transplant and are dealing with a specific type of lymphoma caused by the Epstein-Barr virus. Participating involves receiving a treatment called tabelecleucel and undergoing health assessments to check its effectiveness and safety.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have had a kidney, liver, heart, lung, pancreas, or small bowel transplant.
  • I have a diagnosis of Epstein-Barr virus-related lymphoma.
  • I have had treatment with rituximab or chemotherapy that didn't work.
  • I have measurable disease assessed by imaging.
  • I am willing to provide informed consent.
  • I am healthy enough with good organ function.
  • I am male or female of any age.

You may not be able to join if

  • I currently have an active type of lymphoma that needs treatment.
  • I am taking high doses of steroids or certain other medications.
  • I have untreated central nervous system lymphoma.
  • I have suspected or confirmed severe graft-versus-host disease.
  • I have used certain cancer treatments recently.
  • I am pregnant or breastfeeding.
  • I cannot comply with the study procedures.
  • I have any condition that could make it unsafe for me to participate.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (C-SOT); or prior allogeneic HCT (C-HCT). 2. A diagnosis of locally assessed, biopsy-proven EBV+ PTLD. 3. Availability of appropriate partially HLA-matched and restricted tabelecleucel…
Contacts

Data Protection Officer

+33563714500

dpofr@pierre-fabre.com

CONTACT