Actively Recruiting
Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)
Led by Washington University School of Medicine · Updated on 2025-10-28
12
Participants Needed
1
Research Sites
451 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated biopsy-confirmed CD20-positive monomorphic post-transplant lymphoproliferative disorder or CD20-positive lymphoma associated with immune deficiency after solid organ or stem cell transplant
- At least 18 years of age
- ECOG performance status of 3 or less
- Adequate blood counts and organ function unless affected by lymphoma, including neutrophils 21 1.0 K/cumm, platelets 21 75 K/cumm, hemoglobin 21 8.0 g/dL, bilirubin less than 1.5 times upper limit, liver enzymes less than 2.5 times upper limit, and creatinine clearance over 30 mL/min
- Patients with extensive bone marrow involvement or cytopenias may qualify with neutrophils 21 0.5 K/cumm, platelets 21 50 K/cumm, and hemoglobin 21 7.0 g/dL
- Use of effective contraception for women of childbearing potential and men during the study
- Ability to understand and sign informed consent
You will not qualify if you...
- Active central nervous system involvement with lymphoma or PTLD
- Peripheral neuropathy grade 2 or higher
- Heart ejection fraction below 40%
- Current second cancers requiring active systemic treatment, except non-melanoma skin cancer or carcinoma in situ of the cervix
- Received investigational agents within 4 weeks before study
- History of allergic reaction to polatuzumab vedotin, rituximab, or similar agents
- Uncontrolled illnesses including active infections, lung disease, severe heart failure, unstable angina, or arrhythmia
- Pregnant or breastfeeding women; women of childbearing potential must test negative for pregnancy before treatment
- Active hepatitis B or C infection
- Serious medical conditions or abnormal lab results that would interfere with safe participation or compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
N
Neha Mehta-Shah, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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