Polatuzumab Vedotin and Rituximab for Post-transplant Lymphoproliferative Disorder
This study is testing a combination of two drugs, polatuzumab vedotin and rituximab, for people with a type of cancer called post-transplant lymphoproliferative disorder (PTLD). PTLD can happen after an organ or stem cell transplant. The study is for patients whose PTLD has not been treated before and is CD20-positive, a specific marker found on the cancer cells. Researchers want to see if this combination is safe and works well, potentially helping patients avoid harsher chemotherapy. They also hope to learn more about factors like the tumor's environment and a virus called anellovirus that might affect PTLD. The study plans to enroll 12 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 12 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for side effects for about 5-7 months after treatment ends or a new therapy begins. The study also tracks completion of the treatment regimen, estimated to take 4-6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06040320
Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~12 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Polatuzumab vedotinRituximabCHP
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency and severity of treatment-related adverse events (AEs)
Measured over From start of treatment through 30 days after completion of treatment or initiation of alternative therapy (estimated to be 5-7 months)
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Neha Mehta-Shah, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Previously untreated biopsy-confirmed CD20-positive monomorphic post-transplant lymphoproliferative disorder (or CD20-positive lymphoma associated with immune deficiency) arising after solid organ or hematopoietic stem cell transplant. This may be defined by either the 2016 World Health Organization classification of lymphoid neoplasms or the 2022 International consensus Classification of Mature Lymphoid Neoplasms or the 2022 World Health Organization classification.
At least 18 years of age.
ECOG performance status ≤ 3.
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
Note: Patients with extensive bone marrow involvement by lymphoma and/or disease-related cytopenias may be enrolled if the following criteria are met:
ANC ≥ 0.5 K/cumm
Platelets ≥ 50 K/cumm
Hemoglobin ≥ 7.0 g/dL
The effects of polatuzumab vedotin and rituximab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a participant become pregnant or suspect pregnancy while participating in this study, the participant must inform the treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion
Active central nervous system involvement with lymphoma / PTLD.
Current grade ≥ 2 peripheral neuropathy.
Current ejection fraction \< 40% on transthoracic echocardiogram or multigated acquisition (MUGA) scan
Subjects with history of concurrent second cancers requiring active, ongoing systemic treatment with the following exceptions:
Patients with non-melanoma skin cancer or carcinoma in situ of the cervix will not be excluded.
Patients with previous malignancies are eligible if disease-free for \> 2 years.
Patients on long term hormonal therapy to prevent recurrence of a prior cancer (e.g., hormonal therapy for breast cancer) will not be excluded.
Currently receiving any other investigational agents or received any investigational agents during the 4 weeks prior to the first dose of polatuzumab vedotin.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to polatuzumab vedotin, rituximab, or other agents used in the study.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (bacterial, fungal, viral, parasitic, or mycobacterial), interstitial lung disease, active non-infectious pneumonitis, congestive heart failure NYHA grade ≥ 3, unstable angina pectoris, or cardiac arrhythmia.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to C1D1
Patients with HIV are eligible provided the meet the following criteria:
On antiretroviral regimen and stable on that regimen
Healthy from an HIV perspective
CD4 count \> 250 cells/mcL
Minimal anticipated interactions or overlapping toxicity with polatuzumab vedotin or rituximab
HIV viral load \< 200 copies/mm3 by standard clinical assays
Active hepatitis B infection.
Patients who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation.
Active hepatitis C infection.
Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation.
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.
What this trial measures
- Frequency and severity of treatment-related adverse events (AEs)From start of treatment through 30 days after completion of treatment or initiation of alternative therapy (estimated to be 5-7 months)
- Number of dose-limiting toxicities (DLTs) (Safety Lead-In Cohort only)From start of treatment through cycle 2 (estimated to be 42 days, each cycle is 21 days)
A dose-limiting toxicity (DLT) is defined as an occurrence of an adverse event delineated by the protocol that is at least possibly related to polatuzumab vedotin, rituximab, or the combination within Cycle 1 or Cycle 2.
- Rate of completion of the regimenThrough completion of treatment (estimated to be 4-6 months)