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RECRUITING
NCT06040320
PHASE1/PHASE2

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

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2023-10-04

Completion Date

2032-05-31

Last Updated

2025-10-28

Healthy Volunteers

No

Interventions

DRUG

Polatuzumab vedotin

Given at 1.8 mg/kg

DRUG

Rituximab

Given at 375 mg/m\^2

DRUG

CHP

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