drugset / Trial / NCT06040320
Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-10-04
- Primary completion
- 2027-05-31
- Completion
- 2032-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | — |
| Subject | Polatuzumab Vedotin | Other / unclassified | 1.8 mg/kg | — |
| Subject | Prednisone | Other / unclassified | 100 mg | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |