Actively Recruiting
Defining the Role of ctDNA Monitoring in a Risk Stratified Clinical Trial for Posttransplant Lymphoproliferative Disorder (PTLD)
Led by Jennifer Amengual · Updated on 2026-05-27
30
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Jennifer Amengual
Lead Sponsor
T
The Leukemia and Lymphoma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the benefit of adding rituximab to a chemotherapy regimen called R-EPOCH for people with high-risk B-cell posttransplant lymphoproliferative disorder (PTLD) during the second phase of treatment. Those with low-risk disease will receive rituximab alone without chemotherapy. The study also aims to assess circulating tumor DNA (ctDNA), a new blood test that may help guide treatment decisions and personalize therapy to reduce side effects while maintaining effectiveness. The study is a phase 2, multi-center, open-label trial involving two groups based on risk. Low-risk participants receive four cycles of intravenous rituximab every 21 days. High-risk participants receive four cycles of dose-modified R-EPOCH chemotherapy every 21 days, which includes rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin with specific dosing schedules over several days. The study also uses a device for next-generation sequencing of ctDNA to monitor treatment response. Participants will have scans such as PET-CT or CT before joining and undergo various assessments including blood tests for ctDNA, organ and cardiac function tests, and performance status evaluations. Researchers will monitor treatment response, including complete response rates and progression-free survival over up to three years. Safety and tolerability will be tracked, and participants will be followed regularly during and after treatment to evaluate outcomes and side effects.
CONDITIONS
Brief Title
Defining ctDNA Metrics in Posttransplant Lymphoproliferative Disorder (PTLD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed CD20 positive posttransplant lymphoproliferative disorder (PTLD), including polymorphic or monomorphic subtypes
- Age 15 years or older
- Measurable disease with lymph node size 1.5 cm or larger as defined by Lugano Classification
- PET-CT scan (preferred) or CT chest, abdomen, and pelvis with IV contrast within 28 days before study start
- Screening for chronic hepatitis B virus (HBV) within 28 days prior to registration with undetectable viral load if positive
- Treated and cured hepatitis C virus (HCV) infection or undetectable viral load within 28 days if on treatment
- Known HIV infection allowed if on effective anti-retroviral therapy with undetectable viral load within 26 weeks and CD4 count checked within 28 days
- Organ and cardiac function suitable for rituximab and R-EPOCH as per physician discretion
- ECOG performance status appropriate for treatment
- Ability to understand and willingness to sign informed consent
- Negative pregnancy test within 2 weeks before treatment for women of childbearing potential
- Agreement to use adequate contraception for men and women of childbearing potential
- Agreement to not breastfeed during study
- No chemotherapy for other indications within 4 weeks (6 weeks for certain drugs) prior to study entry
- Prior cumulative doxorubicin dose less than or equal to 250 mg/m2
- Intrathecal chemotherapy allowed for CNS prophylaxis per institution practice
You will not qualify if you...
- Prior systemic chemotherapy for PTLD
- Known lymphomatous involvement of the central nervous system (CNS)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive treatment based on their risk group. Low-risk participants receive rituximab every 21 days for 4 cycles. High-risk participants receive R-EPOCH chemotherapy every 21 days for 4 cycles, including rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin.
4 treatment cycles every 21 days with multiple infusions per cycle
Duration - Up to 3 years
Participants are monitored for treatment response and long-term outcomes including circulating tumor DNA (ctDNA) levels and survival rates for up to 3 years.
Periodic visits for assessments up to 3 years
Trial Site Locations
Total: 2 locations
1
Stanford Medical Center
Stanford, California, United States, 94305
Not Yet Recruiting
2
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
R
Research Nurse Navigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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