Study on Belantamab Mafodotin for Treating Plasmablastic Lymphoma and ALK+ Large B-Cell Lymphoma

Sponsor: Jacob Soumerai, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04676360

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, belantamab mafodotin, for patients with plasmablastic lymphoma or ALK+ large B-cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if belantamab mafodotin, a drug that combines an antibody and a cancer-fighting agent, can safely and effectively treat plasmablastic lymphoma or ALK+ large B-cell lymphoma. The drug works by targeting lymphoma cells and releasing a substance that kills them. This trial is in Phase II, which means it is testing how well the drug works and its safety in treating these specific types of lymphoma. About 25 people are expected to participate, and the drug is not yet approved by the FDA for any disease.

Description

This study involves using belantamab mafodotin, a drug that combines an antibody with a cancer-fighting agent, to treat patients with plasmablastic lymphoma or ALK+ large B-cell lymphoma. Participants will be screened for eligibility and will receive the study treatment, which includes regular evaluations and follow-up visits. The treatment will continue until the disease progresses or the patient can no longer tolerate it, with follow-up lasting up to two years. The study is a Phase II clinical trial, meaning it is testing the drug's safety and effectiveness for these specific lymphomas. The FDA has not approved belantamab mafodotin for any disease, so it is considered investigational, and it is not known if participants will benefit from it.

Eligibility Criteria

Inclusion Criteria

  • Have relapsed or refractory plasmablastic lymphoma or ALK+ large B-cell lymphoma.
  • Have at least one measurable tumor.
  • Have received previous treatment for lymphoma.
  • Be 18 years or older.
  • Be in good general health with a performance status score of 2 or less.
  • Have adequate blood cell counts and organ function.
  • Women must not be pregnant or breastfeeding and must agree to use effective birth control during the study and for four months after.
  • Men must agree to use effective birth control during the study and for six months after.
  • Be able to understand and sign a consent form.

Exclusion Criteria

  • Have current eye problems, except mild corneal changes.
  • Have unstable liver or bile duct disease.
  • Have not recovered from side effects of previous cancer treatments, except hair loss.
  • Be taking other investigational drugs.
  • Have lymphoma in the central nervous system.
  • Use contact lenses during the study.
  • Be in another clinical trial.
  • Have had major surgery within four weeks before starting the study.
  • Have active bleeding or blood disorders.
  • Have allergies to belantamab mafodotin or similar drugs.
  • Have uncontrolled health conditions or infections.
  • Have heart problems or high blood pressure.
  • Be pregnant or breastfeeding.
  • Have hepatitis B or C, or uncontrolled HIV infection.
  • Have another cancer unless it has been stable for at least two years.
  • Have had plasmapheresis within seven days before starting the study.
  • Have received a monoclonal antibody treatment within 30 days before starting the study.

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