NCT06040320

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-transplant Lymphoproliferative Disorder

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-10-04
• Primary completion: 2027-05-31
• Completion: 2032-05-31
• First posted: 2023-09-15
• Last updated: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study