Study on Mosunetuzumab and Chemotherapy for Untreated High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma with C-Myc Rearrangement

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06249191

Provider View

This clinical trial is testing the safety and effectiveness of combining mosunetuzumab, an immunotherapy drug, with chemotherapy to treat patients with certain types of untreated high grade B cell lymphoma or diffuse large B cell lymphoma that have a specific genetic change called c-Myc rearrangement.

Patient Parameters

Program Overview

The study aims to find out if using mosunetuzumab, a type of immunotherapy, along with chemotherapy drugs can safely and effectively treat patients with untreated high grade B cell lymphoma or diffuse large B cell lymphoma that have a c-Myc rearrangement. Mosunetuzumab is a monoclonal antibody that helps the immune system attack cancer cells, while chemotherapy drugs work to stop cancer cells from growing and spreading. The trial will evaluate how well this combination works and its safety for patients.

Description

The main goals of this study are to evaluate the safety and effectiveness of mosunetuzumab combined with chemotherapy drugs (etoposide, doxorubicin, vincristine, cyclophosphamide, and prednisone) in patients with untreated high grade B cell lymphoma or diffuse large B cell lymphoma with c-Myc rearrangement. The study will be conducted in two phases: Phase Ib will focus on safety and tolerability, while Phase II will assess the treatment's effectiveness in achieving a complete response.

Secondary goals include evaluating the overall response, durability of response, and survival rates, as well as monitoring any side effects. The study will also explore the use of tocilizumab for managing side effects and assess the immune response to mosunetuzumab.

Participants will receive mosunetuzumab through an IV on specific days of each treatment cycle, along with chemotherapy drugs. Treatment cycles repeat every 21 days for up to 6 cycles, unless the disease progresses or side effects become unacceptable. Patients will undergo various tests, including scans and blood tests, throughout the study to monitor their health and the treatment's impact.

After completing the treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria

  • Aged 18-75 years with untreated high grade B cell lymphoma or diffuse large B cell lymphoma, confirmed by specific genetic testing.
  • Cancer must be stage II or higher with a specific score indicating disease severity.
  • Able to follow the study protocol and procedures.
  • Have at least one measurable tumor.
  • Provide a tumor sample before starting the study.
  • Good overall health with a specific performance status score.
  • Normal heart function as shown by specific tests.
  • Adequate blood cell counts and organ function.
  • Agree to use effective birth control during and after the study if of childbearing potential or able to produce sperm.

Exclusion Criteria

  • Pregnant or breastfeeding.
  • Previous treatment for diffuse large B cell lymphoma, with some exceptions.
  • Severe allergic reactions to similar drugs.
  • Unable to receive full doses of chemotherapy components.
  • Certain viral infections or immune system disorders.
  • Recent live vaccine administration.
  • Previous organ transplant.
  • History of specific autoimmune diseases, with some exceptions.
  • Current or past central nervous system disease.
  • Recent radiotherapy to specific areas.
  • Other cancers unless in remission for 2 years.
  • Significant uncontrolled diseases or infections.
  • Significant liver or heart disease.
  • Use of certain herbal or cannabis products during the study.

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