Study on Defining Blood Test Metrics in Posttransplant Lymphoproliferative Disorder (PTLD)
Sponsor: Jennifer Amengual
ClinicalTrials ID:NCT06954805
This clinical trial is exploring whether adding chemotherapy to rituximab treatment can benefit patients with high-risk B-cell PTLD, while those with low-risk PTLD may only need rituximab. The study also investigates a new blood test, ctDNA, to see if it can help guide treatment decisions for PTLD.
Patient Parameters
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Program Overview
The aim of this study is to determine if combining rituximab with chemotherapy drugs (R-EPOCH) is beneficial for patients with high-risk B-cell PTLD during their second phase of treatment. Patients with low-risk PTLD may only receive rituximab. Additionally, the study is evaluating a new blood test called circulating tumor DNA (ctDNA) to see if it can help tailor treatments for PTLD, potentially reducing side effects while maintaining treatment effectiveness.
Description
This is a phase 2 clinical trial conducted at multiple centers to test the effectiveness of a modified R-EPOCH treatment in patients with high-risk, untreated CD20+ posttransplant lymphoproliferative disorder (PTLD). The study aims to see if adding chemotherapy to rituximab helps patients with high-risk PTLD, while those with low-risk PTLD might only need rituximab. The trial also examines the use of a new blood test, ctDNA, which has shown promise in guiding treatment decisions in other lymphomas. The goal is to see if ctDNA can be a useful tool in treating PTLD, allowing for personalized treatment plans that minimize side effects without losing effectiveness.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of CD20+ PTLD, including polymorphic and monomorphic subtypes.
- Age 15 or older.
- Must have measurable disease, with a lymph node 1.5 cm or larger.
- Must have a PET-CT scan or CT scan with contrast within 28 days before starting the study.
- Must be screened for hepatitis B within 28 days before joining the study. If positive, must have an undetectable viral load on treatment.
- History of hepatitis C must be treated and cured, or if currently on treatment, must have an undetectable viral load.
- HIV-positive participants must be on effective treatment with an undetectable viral load and have a CD4 count checked within 28 days before joining.
- Must have organ and cardiac function suitable for rituximab and R-EPOCH treatment.
- Must have an ECOG performance status suitable for treatment.
- Must understand and sign a consent form, or have a representative do so if unable.
- Women of childbearing age must have a negative pregnancy test within two weeks of starting treatment.
- Must agree to use contraception and not breastfeed during the study.
- Must not have had chemotherapy for other reasons within four weeks before joining.
- Must not have received more than 250 mg/m² of doxorubicin or similar drugs before joining.
- Intrathecal chemotherapy for CNS prevention is allowed.
Exclusion Criteria
- Have received systemic chemotherapy for PTLD.
- Have known lymphoma involvement of the central nervous system (CNS).
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford Medical Center | 94305 | Stanford | California |
| Columbia University Irving Medical Center | 10032 | New York | New York |
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