Study on Mosunetuzumab and Polatuzumab Vedotin with Split-Dose CHP Chemotherapy for Elderly Patients with Diffuse Large B-Cell Lymphoma

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06594939

Provider View

This clinical trial is testing a new treatment combination for elderly patients newly diagnosed with diffuse large B-cell lymphoma. The study aims to see if adding mosunetuzumab and polatuzumab vedotin to a split-dose chemotherapy regimen can improve patient outcomes.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for elderly patients with a new diagnosis of diffuse large B-cell lymphoma (DLBCL). The trial combines two new drugs, mosunetuzumab and polatuzumab vedotin, with a split-dose chemotherapy regimen. The goal is to see if this combination can improve treatment results. After the first two cycles of treatment, patients will have a scan and a test to check for any remaining cancer. If the results are clear, they will receive a shorter course of treatment.

Description

This clinical trial is designed to test a new combination of treatments for elderly patients with diffuse large B-cell lymphoma (DLBCL). The treatment includes two new drugs, mosunetuzumab and polatuzumab vedotin, given alongside a split-dose chemotherapy regimen. The study aims to see if this combination can improve outcomes for patients.

After the first two cycles of treatment, patients will undergo a scan and a test to check for any remaining cancer. If the results show no signs of cancer, patients will receive a shorter course of treatment, with only four cycles of the combination therapy.

The study is open to patients aged 70-74 who are considered unfit or frail due to other health conditions. Participants must have a new diagnosis of DLBCL and meet specific health criteria, including adequate heart function and a good performance status. The study also requires participants to have a negative HIV test and, if applicable, controlled hepatitis B or C.

Participants will need to provide a tumor sample for testing and agree to follow specific guidelines regarding contraception and other health precautions during the study. The trial aims to provide valuable insights into whether this new treatment combination can offer better outcomes for elderly patients with DLBCL.

Eligibility Criteria

Inclusion Criteria

  • Aged 70-74 and considered unfit or frail due to other health conditions.
  • Newly diagnosed with untreated diffuse large B-cell lymphoma (DLBCL) that is CD20 positive.
  • Have measurable disease by PET/CT scan.
  • Provide a tumor sample for testing.
  • Have good heart function and a performance status score of 50 or higher.
  • Have a life expectancy of more than 3 months.
  • Negative HIV test or controlled HIV with stable treatment.
  • Controlled hepatitis B or C, if applicable.
  • Negative COVID-19 test within 7 days before joining the study.
  • Received at least one dose of a COVID-19 vaccine.
  • Agree to use contraception and follow health guidelines during the study.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Previous treatment for DLBCL with chemotherapy or immunotherapy.
  • Severe nerve damage or certain nerve diseases.
  • Previous stem cell or organ transplant.
  • History of certain viral infections or brain diseases.
  • Positive COVID-19 test within 30 days before starting treatment.
  • Recent live vaccine or on immunosuppressant therapy for autoimmune disease.
  • Significant liver or lung disease.
  • Recent major surgery or radiation therapy.
  • Poor kidney or liver function.
  • Significant heart disease or active infections.
  • Other active cancers or recent cancer treatment.
  • Participation in another clinical trial within 30 days before joining this study.
  • Unable or unwilling to sign consent.

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