Actively Recruiting
A Phase I/II Study of Frontline Therapy With Polatuzumab Vedotin Plus Rituximab in Patients With Post-transplant Lymphoproliferative Disorder
Led by Washington University School of Medicine · Updated on 2026-05-27
12
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of polatuzumab vedotin and rituximab in patients with treatment-naive CD20-positive post-transplant lymphoproliferative disorder (PTLD), a condition that can occur after organ or stem cell transplant. This trial explores whether this combination is safe, tolerable, and effective, aiming to reduce the need for more toxic chemotherapy. The study also investigates the role of the tumor microenvironment and a virus called anellovirus as potential markers for disease prognosis. Participants receive treatment in cycles lasting 21 days. During the first cycle, polatuzumab vedotin and rituximab are given on Day 1, with additional rituximab doses on Days 8 and 15. The second cycle includes polatuzumab vedotin plus rituximab on Day 1. After two cycles, response is assessed. Patients with a complete response continue with polatuzumab vedotin and rituximab for four more cycles, totaling six cycles. Those without a complete response receive the combination plus chemotherapy drugs cyclophosphamide, doxorubicin, and prednisone (CHP) for four cycles, followed by two cycles of CHP alone, totaling eight cycles. During the study, participants undergo regular assessments including scans to evaluate response and lab tests to monitor side effects and organ function. Researchers measure treatment-related adverse events, response rates, and survival over several years. The study lasts approximately 4 to 6 months for treatment, with follow-up for up to five years to monitor long-term outcomes. Participants also agree to contraception use during the trial to prevent pregnancy due to unknown effects of the drugs on developing fetuses.
CONDITIONS
Brief 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 related to immune deficiency after transplant
- At least 18 years of age
- ECOG performance status of 3 or less
- Adequate blood counts and organ function as specified in the study
- Patients with bone marrow involvement or related cytopenias meeting minimum blood count thresholds
- Agreement to use contraception during the study if of childbearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Active central nervous system involvement with lymphoma or PTLD
- Current grade 2 or higher peripheral neuropathy
- Ejection fraction below 40% on heart function tests
- History of other cancers requiring ongoing treatment except certain skin or cervical cancers or disease-free over 2 years
- Use of other investigational agents within 4 weeks prior to study drug
- Allergic reactions to similar drugs used in the study
- Uncontrolled infections or serious medical conditions impacting safety
- Pregnant or breastfeeding women
- Active hepatitis B or C infection
- HIV patients not meeting stability and viral load criteria
- Any condition that may interfere with study participation or safety per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 4 to 6 months
Participants receive polatuzumab vedotin and rituximab during the first 2 cycles. After cycle 2, a response assessment determines further treatment. Participants with a complete response continue polatuzumab vedotin and rituximab for 4 additional 21-day cycles (6 cycles total). Participants without a complete response receive polatuzumab vedotin, rituximab, and CHP for 4 additional 21-day cycles, followed by 2 cycles of CHP alone (8 cycles total).
Multiple visits per 21-day cycle, including Day 1, Day 8, and Day 15 visits during the first cycle, then Day 1 visits in subsequent cycles
Duration - Up to 5 years
Participants are monitored for safety and treatment outcomes for up to 5 years after treatment completion.
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.
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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