ATARA_ALLELE_PTLD (Post-Transplant Lymphoproliferative Disease)

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.

Who Can Participate?

Eligibility

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.

What is Involved?

Description

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

Matthew
McKinney

Protocol Number

PRO00101464

NCT ID

NCT03394365

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov