Study on Polatuzumab Vedotin and Rituximab for Patients with Post-transplant Lymphoproliferative Disorder (PTLD)

Sponsor: Washington University School of Medicine

Sponsor score: 40

ClinicalTrials ID:NCT06040320

Provider View

This clinical trial is testing a combination of two drugs, polatuzumab vedotin and rituximab, to see if they can effectively treat patients with a type of cancer called post-transplant lymphoproliferative disorder (PTLD) that occurs after organ or stem cell transplants. The study aims to find out if this combination is safe, well-tolerated, and more effective than current treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of combining polatuzumab vedotin with rituximab in treating patients with post-transplant lymphoproliferative disorder (PTLD), a type of cancer that can develop after a transplant. Researchers hope this combination will work better than using rituximab alone and help avoid the side effects of more aggressive chemotherapy. The study will also explore how the environment around the tumor and a specific virus might affect the disease and its treatment.

Eligibility Criteria

Inclusion Criteria

  • Have not received prior treatment for CD20-positive post-transplant lymphoproliferative disorder (PTLD) or similar lymphoma after a solid organ or stem cell transplant.
  • Be at least 18 years old.
  • Be in relatively good health, with an ECOG performance status of 3 or lower.
  • Have adequate blood and organ function, unless affected by the lymphoma.
  • Women and men must agree to use effective birth control during the study and inform their doctor if pregnancy is suspected.
  • Be able to understand and sign a consent form to participate in the study.

Exclusion Criteria

  • Have active involvement of the central nervous system with lymphoma or PTLD.
  • Have significant nerve damage (grade 2 or higher).
  • Have a heart function below 40%.
  • Have another active cancer requiring treatment, except for certain skin or cervical cancers, or if cancer-free for over 2 years.
  • Be currently taking other experimental drugs or have taken them within 4 weeks before starting the study.
  • Have allergies to similar drugs used in the study.
  • Have uncontrolled illnesses, such as infections or severe heart or lung conditions.
  • Be pregnant or breastfeeding.
  • Have HIV, unless stable on treatment with a low viral load and good immune health.
  • Have active hepatitis B or C infections, unless specific conditions are met.
  • Have any serious medical condition that could interfere with the study or its results.

Locations

FACILITYZIPCITYSTATE
Washington University School of Medicine63110St LouisMissouri

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