RecruitingPhase 1Phase 2NCT06040320

Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)

A Phase I/II Study of Frontline Therapy With Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)


Sponsor

Washington University School of Medicine

Enrollment

12 participants

Start Date

Oct 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study will test polatuzumab vedotin in combination with rituximab in patients with treatment-naïve CD20-positive post-transplant lymphoproliferative disorder (PTLD) based on the established efficacy of polatuzumab vedotin in B-cell lymphomas and the inadequate response rate of PTLD to single-agent rituximab. The hypothesis is that this combination therapy will be safe, well-tolerated, and effective. If so, patients with PTLD will be able to be spared the toxicity of anthracycline-based chemotherapy. Additionally, the role of the tumor microenvironment and the role of anellovirus, a non-human pathogen virus, will be explored as prognostic markers in PTLD.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — polatuzumab vedotin and rituximab — to treat a rare type of lymphoma called post-transplant lymphoproliferative disorder (PTLD), which can develop in people who have had an organ or bone marrow transplant and are on immune-suppressing medications. **You may be eligible if...** - You are 18 or older - You developed a type of lymphoma (PTLD) after receiving a solid organ transplant or bone marrow/stem cell transplant - Your lymphoma is confirmed to be CD20-positive (a protein marker on the cancer cells) and has not been treated before - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have already received treatment for this lymphoma - Your liver or kidney function is significantly impaired - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPolatuzumab vedotin

Given at 1.8 mg/kg

DRUGRituximab

Given at 375 mg/m\^2

DRUGCHP

Cyclophosphamide (750 mg/m\^2) + doxorubicin (50 mg/m\^2) + prednisone (100 mg days 2-6)


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06040320


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