OncoMatch/Clinical Trials/NCT06040320
Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)
Is NCT06040320 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Polatuzumab vedotin and Rituximab for post-transplant lymphoproliferative disorder.
Treatment: Polatuzumab vedotin · Rituximab · CHP — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: MS4A1 overexpression (CD20-positive)
biopsy-confirmed CD20-positive monomorphic post-transplant lymphoproliferative disorder (or CD20-positive lymphoma associated with immune deficiency)
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.0 K/cumm (or ≥ 0.5 K/cumm if disease-related cytopenias); Platelets ≥ 75 K/cumm (or ≥ 50 K/cumm if disease-related cytopenias); Hemoglobin ≥ 8.0 g/dL (or ≥ 7.0 g/dL if disease-related cytopenias)
Kidney function
Creatinine clearance > 30 mL/min measured or by Cockcroft-Gault
Liver function
Total bilirubin < 1.5 x IULN; AST(SGOT)/ALT(SGPT) < 2.5 x IULN
Cardiac function
Current ejection fraction < 40% on transthoracic echocardiogram or MUGA scan [excluded]
Adequate hematologic and organ function (unless due to underlying lymphoma per the investigator) as defined below: Absolute neutrophil count ≥ 1.0 K/cumm; Platelets ≥ 75 K/cumm; Hemoglobin ≥ 8.0 g/dL; Total bilirubin < 1.5 x IULN; AST(SGOT)/ALT(SGPT) < 2.5 x IULN; Creatinine clearance > 30 mL/min measured or by Cockcroft-Gault. Patients with extensive bone marrow involvement by lymphoma and/or disease-related cytopenias may be enrolled if: ANC ≥ 0.5 K/cumm; Platelets ≥ 50 K/cumm; Hemoglobin ≥ 7.0 g/dL. Current ejection fraction < 40% on transthoracic echocardiogram or MUGA scan [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University School of Medicine · St Louis, Missouri
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