Study Comparing Standard Treatment for Hodgkin Lymphoma with Two New Drugs: Brentuximab Vedotin and Nivolumab

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05675410

Provider View

This clinical trial is testing whether adding two new drugs, brentuximab vedotin and nivolumab, to the standard treatment for early-stage Hodgkin lymphoma can improve survival rates. The study aims to see if this combination is more effective than the standard treatment alone, which includes chemotherapy and possibly radiation.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding two new drugs, brentuximab vedotin and nivolumab, to the standard treatment for Hodgkin lymphoma can help patients live longer. Brentuximab vedotin is a type of drug that targets cancer cells directly, while nivolumab helps the immune system attack cancer. The standard treatment usually involves chemotherapy and sometimes radiation. This study will compare the effectiveness of the new combination against the standard treatment alone in patients with early-stage Hodgkin lymphoma.

Description

Primary Goals:

  1. To compare how long patients live without the cancer getting worse when treated with standard chemotherapy versus the new combination of brentuximab vedotin and nivolumab.
  2. To see if adding radiation to the new drug combination helps patients who don't respond quickly to initial treatment.

Secondary Goals:

  1. To check if the new drug combination is as good as the standard treatment in helping patients live longer.
  2. To evaluate the safety and side effects of the new treatment compared to the standard treatment.
  3. To assess how the treatment affects patients' quality of life, including fatigue and cognitive function.
  4. To explore how different factors like race and ethnicity might affect treatment outcomes.

Study Design:

  • Patients will be divided into groups based on their risk level and response to initial treatment.
  • All patients will start with two cycles of standard chemotherapy.
  • Depending on their response, patients will be assigned to different treatment groups, which may include additional chemotherapy, the new drug combination, and possibly radiation.
  • Patients will undergo various scans and tests throughout the study to monitor their progress.

Follow-Up:

  • After completing the study treatment, patients will have regular follow-up visits to monitor their health and any long-term effects of the treatment.

Inclusion Criteria:

  • Ages 5 to 60 with newly diagnosed, untreated Hodgkin lymphoma.
  • Must have measurable disease and a recent PET scan.
  • Good overall health and organ function.
  • Willingness to follow study procedures and provide informed consent.

Exclusion Criteria:

  • Other types of Hodgkin lymphoma or uncontrolled health conditions.
  • Recent use of certain medications or treatments.
  • Pregnant or breastfeeding women.
  • Patients not willing to use effective contraception during and after the study.

Eligibility Criteria

Inclusion Criteria

  • Ages 5 to 60 years old.
  • Newly diagnosed with untreated classic Hodgkin lymphoma (stage I or II).
  • Must have at least one tumor that can be measured.
  • Recent PET scan required.
  • Good kidney and liver function.
  • Good heart and lung function.
  • HIV-positive patients must have controlled viral load.
  • Hepatitis B or C patients must have controlled or treated infection.

Exclusion Criteria

  • Different type of Hodgkin lymphoma.
  • History of lung disease or uncontrolled health issues.
  • Recent use of certain medications or treatments.
  • Pregnant or breastfeeding women.
  • Not willing to use effective contraception during and after the study.

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