Duke logo

ANHL1522- Rituximab and Immune Cells from Donors to Treat PTLD - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if we can improve the treatment for patients with PTLD by treating patients with special immune system cells called LMP-specific T cells.

These cells come from donors and are tested to find out which cells are a match for each patient.

What is the Condition Being Studied?

Post-Transplant Lymphoproliferative Disease (PTLD)

Who Can Participate in the Study?

Children and young adults who:
- Are Age 29 or younger
- Have a history of solid organ transplantation
- Are newly diagnosed polymorphic or monomorphic PTLD
- Have measurable disease
- Recovered from previous chemotherapy, immunotherapy, or radiotherapy

Age Group
Adults, Children

What is Involved?

If you choose to be in this study, you will:
- Begin study treatment LMP-specific T cells (LMP-TC) with three doses of anti-B-cell medicine rituximab once a week for 21 days
- Get imaging scans to look at your tumor size

- After induction chemotherapy (first line of treatment for cancer), you will be put into one of the following groups:
A) Get another 21-day course of rituximab
B) Get either 1 or 2 six week courses of LMP-specific T cells

Study Details

Full Title
ANHL1522- A Pilot Study of Rituximab (RTX) and Third Party Latent Membrane Protein (LMP)-Specific Cytotoxic T-Lymphocytes (LMP-TC) in Pediatric Solid Organ Recipients (SOT) With EBV-Positive CD20-Positive Post-Transplant Lymphoproliferative Disease (PTLD)
Principal Investigator
Pediatric Hematology-Oncology Specialist
Protocol Number
IRB:PRO00082215
NCT:NCT02900976
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698