ATARA_ALLELE_PTLD (Post-Transplant Lymphoproliferative Disease) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called tabelecleucel is effective for the treatment of EBV-associated post-transplant lymphoproliferative disease (EBV+ PTLD). We want to know if it is beneficial for people with EBV+PTLD who have received either a solid organ transplant or an allogeneic hematopoietic cell transplant.

What is the Condition Being Studied?

Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (PTLD)

Who Can Participate in the Study?

Adults with EBV+PTLD who:
- Have received a solid organ transplant and failed rituximab therapy; OR
- Have received a solid organ transplant and failed rituximab combined with chemotherapy; OR
- Have received an allogeneic hematopoietic cell transplant and failed rituximab therapy

For more information about who can join this study, please contact the study team at 919-681-6580.

Age Group
Adults, Children

What is Involved?

This study has three parts: the screening period, the study drug period, and the follow up period.

We will find out during the screening period if you are eligible to enter the study drug period. During the screening period, you will:
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws
- Have PET/CT scans

If you are eligible for the study drug period, you will be assigned to either the solid organ transplant group or the hematopoietic cell transplant group. In either group, you will receive study drug through infusions (IV) on days 1, 8 and 15 of dosing cycles that each last for 35 days.

You will begin the follow up period after the study drug period ends. During the follow up period, you will:
- Have blood draws
- Have PET/CT scans

The follow up period will last up to 5 years.

Study Details

Full Title
Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)
Principal Investigator
Cellular Therapy Specialist
Protocol Number
IRB: PRO00101464
NCT: NCT03394365
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698