Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed or Hard-to-Treat Diffuse Large B-cell Lymphoma

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05633615

Provider View

This study is exploring whether adding the drugs mosunetuzumab and/or polatuzumab vedotin after CAR T-cell therapy can help control or shrink cancer in patients with diffuse large B-cell lymphoma that has returned or is not responding to treatment.

Patient Parameters

Program Overview

This phase II clinical trial is investigating if the drugs mosunetuzumab and polatuzumab vedotin can help patients with diffuse large B-cell lymphoma that has come back or is not responding to treatment. These patients have already received chemotherapy and CAR T-cell therapy. Mosunetuzumab and polatuzumab vedotin are types of targeted therapies that aim to stop cancer cells from growing and spreading. The study aims to see if these drugs can be more effective when given after the initial treatments.

Description

The main goal of this study is to see if adding mosunetuzumab and/or polatuzumab vedotin after CAR T-cell therapy can help patients with relapsed or hard-to-treat large B-cell lymphoma or grade 3B follicular lymphoma. The study will compare how long patients live without the cancer getting worse when they receive these additional treatments versus when they do not.

Participants will be divided into four groups:

  • Group 1 will receive mosunetuzumab.
  • Group 2 will receive polatuzumab vedotin.
  • Group 3 will receive both mosunetuzumab and polatuzumab vedotin.
  • Group 4 will be observed without additional treatment, but may switch to Group 3 if their cancer progresses.

The study will also look at overall survival rates, complete remission rates, and any side effects from the treatments. Blood and tissue samples will be collected for further research.

Participants will undergo PET-CT scans to monitor their response to the treatments. The study will also bank specimens and images for future research.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of diffuse large B-cell lymphoma, grade 3B follicular lymphoma, or primary mediastinal large B-cell lymphoma.
  • Must have measurable disease with at least one tumor larger than 1.5 cm.
  • Must be asymptomatic if there is central nervous system involvement.
  • Must be eligible for CAR T-cell therapy and have signed consent for leukapheresis.
  • Must not have received mosunetuzumab or polatuzumab vedotin as bridging therapy.
  • Must have a PET-CT scan planned within 60 days before starting chemotherapy.
  • Must be 18 years or older.
  • Must have adequate organ function and meet specific blood test criteria.
  • Must not have severe heart disease or recent heart attacks.
  • Must have controlled viral infections if applicable (HIV, hepatitis B, or C).
  • Must agree to participate in specimen banking for future research.

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