RecruitingPhase 2NCT04679012

Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation

Phase II Study of Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation

Sponsor

Weill Medical College of Cornell University

Enrollment

20 participants

Start Date

Sep 24, 2021

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Richter Syndrome

Summary

This study evaluates the effectiveness and safety of Polatuzumab vedotin plus infusional chemoimmunotherapy containing rituximab, etoposide, prednisone, cyclophosphamide and hydroxydaunorubicin. This is a single arm study. Enrolled patients will receive up to six cycles (21-day cycles) of therapy. While on study, subjects will be monitored weekly until end of treatment, then followed for 52 weeks or until disease progression or discontinuation due to toxicity or death. After completion of the 52-week follow-up/End of study visit, Subjects will be followed for an additional 104 week period, with an assessment occurring every 12 weeks to evaluate survival outcomes and next line of treatments only.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called polatuzumab vedotin (an antibody-drug conjugate that delivers chemotherapy directly to cancer cells) in combination with chemotherapy for patients with Richter's Transformation — a serious condition where a slow-growing type of blood cancer called chronic lymphocytic leukemia (CLL) transforms into a fast-growing, aggressive lymphoma (DLBCL). **You may be eligible if you:** - Have been diagnosed with CLL or small lymphocytic lymphoma (SLL) that has transformed into aggressive diffuse large B-cell lymphoma (DLBCL), confirmed by biopsy - Are 18 years of age or older - Are in adequate health (ECOG performance status 0–2) - Have measurable disease on imaging (at least one lymph node larger than 1.5 cm) - Have adequate bone marrow and organ function - Have a life expectancy of at least 24 weeks **You may NOT be eligible if you:** - Have CLL that has not transformed into DLBCL - Have very poor organ function or bone marrow failure - Cannot tolerate the study drug combination Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPolatuzumab Vedotin

Polatuzumab vedotin will be administered as an IV infusion at 1.8mg/kg on Day 1 of each cycle, every 21 days.

DRUGRituximab

Rituximab will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.

DRUGEtoposide

Etoposide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.

DRUGPrednisone

Prednisone will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. Prednisone will be given orally.

DRUGCyclophosphamide

Cyclophosphamide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.

DRUGHydroxydaunomycin

Hydroxydaunomycin will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.