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Chemotherapy

Polatuzumab + Rituximab for Lymphoproliferative Disorders

Phase 1 & 2

Recruiting

Led By Neha Mehta-Shah, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 5 years from completion of treatment (estimated to be between 64 and 66 months)

Awards & highlights

Study Summary

This trial will test a new combination of drugs to treat post-transplant lymphoproliferative disorder, with the aim of sparing patients from toxic chemotherapy. It will also examine how viruses and the tumor microenvironment affect the disorder's prognosis.

Who is the study for?

This trial is for adults with CD20-positive post-transplant lymphoproliferative disorder (PTLD) who haven't been treated before. They should have adequate blood counts, organ function, and be able to consent. Pregnant or breastfeeding individuals are excluded, as well as those with certain infections, heart conditions, neuropathy, or other serious health issues.Check my eligibility

What is being tested?

The study tests polatuzumab vedotin combined with rituximab in patients with PTLD. It aims to see if this combo can avoid the toxicity of traditional chemotherapy while being safe and effective. The trial will also examine tumor environment factors and anellovirus presence as potential prognostic markers.See study design

What are the potential side effects?

Possible side effects include allergic reactions similar to those from drugs like polatuzumab vedotin or rituximab; however specific side effects aren't listed here but may align with known profiles of these medications which typically involve immune system reactions and infusion-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a type of lymphoma that developed after an organ or stem cell transplant and hasn't been treated yet.

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I agree to use birth control or abstain from sex during the study.

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I can care for myself but may not be able to do any physical work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 5 years from completion of treatment (estimated to be between 64 and 66 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 5 years from completion of treatment (estimated to be between 64 and 66 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 years from completion of treatment (estimated to be between 64 and 66 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency and severity of treatment-related adverse events (AEs)

Number of dose-limiting toxicities (DLTs) (Safety Lead-In Cohort only)

Rate of completion of the regimen

Secondary outcome measures

Best overall response

Complete metabolic response (CR) rate by PET/CT

Duration of response

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission))Experimental Treatment3 Interventions

Cycle 1 (21 days) Day 1: polatuzumab vedotin + rituximab Day 8: rituximab Day 15: rituximab Cycle 2 (21 days) Day 1: polatuzumab vedotin + rituximab After Cycle 2, a response assessment will be performed. Patients who show anything other than a complete response (and are therefore determined to be high risk) will receive polatuzumab vedotin + rituximab + CHP (cyclophosphamide + doxorubicin + prednisone) on Day 1 of each 21-day cycle for 4 additional cycles, followed by 2 final cycles of CHP alone on Day 1 (8 cycles of treatment total).

Group II: Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission)Experimental Treatment3 Interventions

Group III: Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission)Experimental Treatment2 Interventions

Cycle 1 (21 days) Day 1: polatuzumab vedotin + rituximab Day 8: rituximab Day 15: rituximab Cycle 2 (21 days) Day 1: polatuzumab vedotin + rituximab After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total).

Group IV: Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission)Experimental Treatment2 Interventions

Cycle 1 (21 days) Day 1: polatuzumab vedotin + rituximab Day 8: rituximab Day 15: rituximab Cycle 2 (21 days) Day 1: polatuzumab vedotin + rituximab After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,683 Total Patients Enrolled

Neha Mehta-Shah, M.D.Principal InvestigatorWashington University School of Medicine

4 Previous Clinical Trials

119 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available in this medical investigation?

"Correct. The clinicaltrials.gov page for this study states that recruitment has concluded, as the trial was first posted on October 31st 2023 and last updated September 9th 2023. Presently there are 51 other medical studies actively searching for volunteers."

Answered by AI

What is the purpose of this clinical exploration?

"The primary outcome of this medical trial is the number of dose-limiting toxicities (DLTs) observed in patients over a period of 5-7 months, starting from treatment initiation to 30 days after completion. Secondary outcomes include overall response rate (ORR), best overall response, and duration of response as per Lugano Response Criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)

2023. "Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06040320.