Ongoing Clinical Trials for Post Transplant Lymphoproliferative Disorder
Post Transplant Lymphoproliferative Disorder (PTLD) is a serious complication that can occur after organ or stem cell transplantation, often linked to the Epstein-Barr virus. Currently, there is 1 ongoing clinical trial investigating new treatment options for patients with this condition who have not responded to standard therapies. This trial is being conducted across multiple European countries and focuses on a novel cell-based therapy called tabelecleucel.
Clinical trial locations
- Austria
- Belgium
- France
- Italy
- Spain
Study of Tabelecleucel for Patients with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Transplant Treatment Failure
This Phase 3 clinical trial is investigating a new treatment approach for patients who have developed Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease following organ or stem cell transplantation. The study focuses on patients whose disease has not responded to standard treatments and aims to evaluate whether tabelecleucel, a specialized cell therapy, can provide clinical benefit.
Main inclusion criteria:
- Patients must have previously undergone either a solid organ transplant (such as kidney, liver, heart, lung, pancreas, or small bowel) or an allogeneic hematopoietic cell transplant (bone marrow transplant)
- A confirmed diagnosis of Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease
- The disease must be measurable on imaging tests such as PET scans or MRI
- Previous treatment with rituximab or a similar medication must have failed, or the disease must have returned after initial treatment
- Patients of any age, male or female, can participate
- For patients aged 16 and older, a performance status of 3 or less is required; for those under 16, a Lansky score of 20 or more
- Adequate organ function, including acceptable levels of white blood cells (neutrophils), platelets, and liver function tests
- A suitable partially matched tabelecleucel treatment must be available
Main exclusion criteria:
- Patients who have not previously tried and failed rituximab or chemotherapy treatments
- Patients who have not undergone a solid organ transplant or allogeneic hematopoietic cell transplant
- Patients who fall outside the specific study groups or age range
- Those who do not meet other specific health requirements for the study
Study focus and goals:
The primary goal of this trial is to determine whether tabelecleucel provides clinical benefit for patients with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease who have not responded to previous treatments. The study will evaluate the objective response rate, which measures how many patients show improvement or reduction in their disease. Additionally, researchers will monitor the duration of response and overall survival among participants. The trial uses regular imaging assessments to track how the disease responds to treatment over time. The study is expected to continue until June 2027 to gather comprehensive data.
Investigational drugs:
The main treatment being studied is tabelecleucel (also known as ATA129), an innovative immunotherapy that uses specially prepared immune cells called T cells. These T cells are designed to recognize and attack cells infected with the Epstein-Barr virus. Tabelecleucel is administered intravenously at a dosage ranging from 2.8 × 10^7 to 7.3 × 10^7 cells/mL. The therapy works by targeting virus-infected cells, helping the immune system control or eliminate the disease when conventional treatments have been unsuccessful.
The study also involves rituximab, a medication commonly used to treat certain cancers and autoimmune diseases. Rituximab targets a specific protein on the surface of certain immune cells, leading to their destruction. In this trial, rituximab represents the previous standard treatment that patients received before being considered for tabelecleucel.
Chemotherapy is also referenced in the trial as part of combination treatments that were previously attempted. The study specifically focuses on patients for whom rituximab alone or combined with chemotherapy did not work, exploring whether tabelecleucel can offer additional therapeutic benefits.
Summary
Currently, there is one active clinical trial for Post Transplant Lymphoproliferative Disorder, specifically targeting the Epstein-Barr Virus-Associated form of the disease. This trial is notable for its wide geographic reach across Europe, with sites in Austria, Belgium, France, Italy, and Spain, making it accessible to patients in multiple countries.
The trial represents an important advancement in treatment options for patients who have exhausted standard therapies. By focusing on tabelecleucel, a specialized cell-based immunotherapy, the study explores a novel approach that harnesses the body’s immune system to fight virus-infected cells. This is particularly significant for transplant recipients who face limited options after failing rituximab-based treatments.
The inclusive nature of the trial, accepting patients of all ages who meet the medical criteria, reflects the need for treatment options across different patient populations affected by this serious post-transplant complication. The extended timeline through 2027 will allow researchers to gather substantial data on the long-term effectiveness and safety of this innovative therapy.