Study on Polatuzumab Vedotin with Chemotherapy for Patients with Richter's Transformation

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04679012

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment combining Polatuzumab Vedotin with chemotherapy for patients with Richter's Transformation, a type of cancer that develops from chronic lymphocytic leukemia (CLL). Participants will receive up to six cycles of treatment and be monitored for up to two years.

Patient Parameters

Program Overview

The study aims to evaluate how well Polatuzumab Vedotin, combined with a chemotherapy regimen including rituximab, etoposide, prednisone, cyclophosphamide, and hydroxydaunorubicin, works in treating patients with Richter's Transformation. This is a single-arm study, meaning all participants will receive the same treatment. Patients will undergo up to six cycles of therapy, each lasting 21 days. They will be closely monitored during treatment and followed for 52 weeks after treatment ends, or until the disease progresses or they experience severe side effects. After this period, participants will continue to be monitored every 12 weeks for an additional two years to assess their survival and any further treatments they may receive.

Description

This is an open-label, single-arm, phase II clinical trial designed to test the effectiveness and safety of adding Polatuzumab Vedotin to a modified chemotherapy regimen similar to R-EPOCH. The treatment is given in a hospital setting every 21 days to patients with Richter's Transformation, a condition where chronic lymphocytic leukemia (CLL) transforms into a more aggressive form of lymphoma. The study will assess how well the treatment works and its safety profile.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) that has transformed into a type of lymphoma called diffuse large B-cell lymphoma (DLBCL).
  • Must be 18 years or older.
  • Must be able to understand and sign a consent form.
  • Must be willing to follow the study procedures.
  • Must have a life expectancy of at least 24 weeks.
  • Must have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Must have measurable disease, with at least one lymph node larger than 1.5 cm.
  • Must have adequate bone marrow function, including:
    • Neutrophil count of at least 1000 cells/uL.
    • Hemoglobin level of at least 7 g/dL.
    • Platelet count of at least 30,000 cells/uL.
  • Must have adequate organ function, including:
    • Total bilirubin level within 1.5 times the normal limit (exceptions for Gilbert's disease).
    • Creatinine clearance greater than 30 ml/min/1.73m2.
    • Heart ejection fraction of at least 50%.
  • Women of childbearing potential must agree to use effective contraception during treatment and for 12 months after.
  • Men must agree to use a condom and another form of contraception during treatment and for 5 months after, and not donate sperm during this time.

Exclusion Criteria

  • Diagnosis of Richter's Transformation that is not of the DLBCL subtype.
  • Previous treatment specifically targeting Richter's Transformation.
  • Recent use of targeted therapies like BTKi, venetoclax, or PI3K inhibitors before joining the study.
  • Allogeneic stem cell transplant for CLL within 6 months before the study.
  • Active or suspected secondary cancer at the time of joining the study, unless previously treated with no recurrence for 3 years.
  • Positive for HIV.
  • Active hepatitis B or C infection.
  • Severe nerve damage (Grade 2 or higher).
  • Severe allergic reactions to certain antibodies.
  • Cancer spread to the central nervous system.
  • Uncontrolled health conditions that could interfere with the study.
  • Significant heart disease or recent heart attack.
  • Active infections requiring treatment or hospitalization within 4 weeks before starting the study.
  • Major surgery within 4 weeks before starting the study.

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