Study on Antibody and Immunotherapy with Chemotherapy for Primary Mediastinal Large B-cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04745949

Provider View

This clinical trial is exploring a new treatment approach for patients with untreated primary mediastinal large B-cell lymphoma, using a combination of antibody therapy, immunotherapy, and chemotherapy to see if it can effectively control the disease with fewer side effects than standard treatments.

Patient Parameters

Program Overview

This study is testing a combination of treatments for patients with primary mediastinal large B-cell lymphoma (PMBL) who have not yet received treatment. The trial involves using brentuximab vedotin and nivolumab, which are types of antibody and immunotherapy, along with chemotherapy drugs rituximab, cyclophosphamide, doxorubicin, and prednisone. The goal is to see if this combination can effectively treat the cancer while being less harmful than traditional chemotherapy.

Description

The main goal of this study is to see how well the combination of brentuximab vedotin and nivolumab works alone and then together with rituximab, cyclophosphamide, doxorubicin, and prednisone in treating primary mediastinal large B-cell lymphoma (PMBL). Researchers will also look at how safe and tolerable the treatment is, how it affects patients' quality of life, and how long patients survive without the cancer coming back.

Patients will first receive two cycles of brentuximab vedotin and nivolumab. If the treatment shows promise, they will continue with additional cycles that include rituximab, cyclophosphamide, doxorubicin, and prednisone. The treatment cycles last 21 days each, and the total treatment can last up to eight cycles, depending on the patient's response. After completing the treatment, patients will be monitored regularly to check their health and the status of their cancer.

The study aims to provide a new treatment option that could be more effective and less harmful than current standard therapies for PMBL.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary mediastinal large B-cell lymphoma (PMBL) with a CD30 expression level of 1% or higher.
  • No previous treatment, except for limited radiotherapy or a short course of steroids.
  • Cancer stage II, III, IV, or stage I with a tumor size of 5 cm or larger.
  • Able to understand and sign a consent form.
  • Aged 18 years or older.
  • Have measurable disease with a tumor size of at least 1.5 cm.
  • Performance status of 3 or lower, if related to lymphoma.
  • Normal liver and kidney function, with specific blood test results within acceptable ranges.
  • Willing to receive blood transfusions if needed.
  • Women of childbearing potential must have a negative pregnancy test and use effective birth control during and after the study.
  • Men must agree to use birth control and not donate sperm during and after the study.

Exclusion Criteria

  • Urgent need for treatment to reduce tumor size.
  • Serious medical conditions like uncontrolled heart disease, diabetes, or infections.
  • Previous exposure to certain chemotherapy drugs above a specific limit.
  • Pregnant or breastfeeding women.
  • Allergies to any of the study drugs.
  • Active HIV infection with detectable virus levels.
  • Active hepatitis B or C infections.
  • Cancer spread to the brain or spinal cord.
  • Recent history of other cancers, except for certain skin cancers or cancers in remission.
  • Significant nerve damage or neuropathy.
  • Unable to take required medications or treatments.
  • Recent major surgery or unhealed wounds.
  • Recent stroke or brain bleeding.
  • Recent vaccination with live vaccines.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.