Study on Brentuximab Vedotin and Nivolumab for Treating Relapsed or Hard-to-Treat Classic Hodgkin Lymphoma

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05039073

Provider View

This clinical trial is exploring the use of two drugs, brentuximab vedotin and nivolumab, to treat patients with classic Hodgkin lymphoma that has returned or is not responding to treatment. The study focuses on patients who have already been treated with either brentuximab vedotin or checkpoint inhibitors.

Patient Parameters

Program Overview

This study is testing a combination of two drugs, brentuximab vedotin and nivolumab, to see if they can effectively treat classic Hodgkin lymphoma that has come back or is not responding to treatment. Brentuximab vedotin targets and kills cancer cells, while nivolumab helps the immune system attack the cancer. The trial aims to find out if using these drugs together can be a successful treatment for patients who have already tried other therapies.

Description

The main goals of this study are to see how well the combination of brentuximab vedotin and nivolumab works in patients who have previously been treated with these drugs or similar therapies. Researchers want to measure how many patients respond to the treatment and how long they stay free from cancer progression. They will also look at the safety and side effects of the treatment, as well as how it affects patients' quality of life.

Patients in the study will receive brentuximab vedotin and nivolumab through an IV every 21 days for up to 16 cycles, unless the cancer progresses or side effects become too severe. If patients show a good response after 4 cycles, they may stop the study treatment to undergo a stem cell transplant.

After finishing the treatment, patients will have follow-up visits at 30 days, every 3 months for 2 years, and then every 6 months for 3 years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of classic Hodgkin lymphoma.
  • Must be 12 years or older.
  • Must have received 1-2 prior chemotherapy or immunotherapy treatments.
  • Must not have had a stem cell transplant before.
  • Must have a performance status score indicating they are able to carry out daily activities.
  • Must have a tumor or lymph node that is at least 1.5 cm in size.
  • Must have recovered from any previous treatment side effects.
  • Must have adequate blood cell counts and organ function.
  • Patients with HIV are eligible if they meet specific health criteria.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must have completed any previous cancer treatments at least 2 weeks before starting the study.
  • Must be willing to follow study procedures and attend all scheduled visits.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Have had another type of cancer within the last 2 years, except for certain skin or cervical cancers.
  • Have received chemotherapy or radiotherapy within 2 weeks before starting the study.
  • Have an active autoimmune disease or history of such diseases.
  • Have active central nervous system involvement with lymphoma.
  • Have hepatitis B or C infections.
  • Have any active infections or other serious health conditions that would interfere with the study.

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