Actively Recruiting
Defining ctDNA Metrics in Posttransplant Lymphoproliferative Disorder (PTLD)
Led by Jennifer Amengual · Updated on 2025-05-02
30
Participants Needed
2
Research Sites
156 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
The purpose of this study is to find out if there is a benefit to giving rituximab with etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (R-EPOCH) in participants who have high-risk B-cell PTLD in their 2nd phase of treatment (consolidation) while those with low-risk disease will be spared of chemotherapy and treated with rituximab consolidation alone. This study is also being done to find out about the usefulness of circulating tumor DNA (ctDNA), a novel blood test which, has been shown to help guide treatment decisions in other types of lymphoma. The goal is to answer the question if ctDNA is a viable and informative tool in treating PTLD with the hope that in the future it may be used to individualize study treatment for participants with PTLD in a way that limits study treatment toxicity without losing the effectiveness of the treatment plan.
CONDITIONS
Official Title
Defining ctDNA Metrics in Posttransplant Lymphoproliferative Disorder (PTLD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed CD20+ PTLD including polymorphic and monomorphic subtypes
- Age 15 years or older
- Measurable disease with lymph node size of 1.5 cm or greater per Lugano Classification
- PET-CT scan (preferred) or CT chest, abdomen, and pelvis with IV contrast within 28 days prior to study start
- Screening for chronic hepatitis B virus (HBV) within 28 days prior to registration; if positive, undetectable HBV viral load on suppressive therapy within 28 days prior to treatment
- History of hepatitis C virus (HCV) infection must be treated and cured; active infection must have undetectable viral load within 28 days prior to registration
- Participants with HIV infection must be on effective anti-retroviral therapy with undetectable viral load within 26 weeks prior to registration; CD4 count checked within 28 days prior to registration
- Organ and cardiac function suitable for rituximab and R-EPOCH as determined by treating physician
- Eastern Cooperative Oncology Group (ECOG) performance status suitable for rituximab and R-EPOCH
- Ability to understand and willingness to sign informed consent; legally authorized representative may consent if participant has impairments
- Women of childbearing age must have documented negative serum beta-hCG within 2 weeks of starting treatment
- Both women of childbearing potential and men must agree to use adequate contraception
- Women must agree not to breastfeed during the study
- No chemotherapy for other indications within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry, and recovered from adverse events from earlier treatments
- Cumulative prior doxorubicin dose must not exceed 250 mg/m2 (or equivalent anthracycline dose)
- Intrathecal chemotherapy for CNS prophylaxis allowed per institutional practice in addition to protocol therapy
You will not qualify if you...
- Prior systemic chemotherapy for PTLD
- Known lymphomatous involvement of the central nervous system (CNS)
AI-Screening
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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
CONTACT
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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