Study on BrECADD Therapy for Stage 2 B-IV Hodgkin Lymphoma

Sponsor: University of Miami

Sponsor score: 40

ClinicalTrials ID:NCT07002216

This clinical trial is testing a combination of drugs called BrECADD to see if it is effective and well-tolerated in patients with advanced Hodgkin Lymphoma. The study also aims to explore if a blood test can help track the disease and treatment response.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a drug combination called BrECADD in treating patients with advanced stages of Hodgkin Lymphoma (Stage 2 B-IV). The study will also investigate if a blood test, known as circulating tumor DNA (ctDNA), can be used to monitor the disease and how well the treatment is working.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 60 years with a confirmed diagnosis of classical Hodgkin Lymphoma.
  • Must have cancer that shows up on specific scans and have at least one measurable tumor.
  • Cancer must be at Stage 2 B with certain risk factors, or Stage III or IV.
  • Must be in relatively good health with a performance status score of 2 or less.
  • Life expectancy of at least 3 months.
  • Women must use effective birth control during treatment and for 6 months after, as the treatment may affect hormonal contraceptives.
  • Men must use barrier contraception if their partner is of childbearing potential.
  • Must have normal organ and bone marrow function as shown by specific blood tests.
  • Must be able to understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • Have Stage I or IIA Hodgkin Lymphoma.
  • Have a different type of Hodgkin Lymphoma called nodular lymphocyte-predominant.
  • Have had previous treatment for lymphoma, except for certain types of indolent lymphoma.
  • Have uncontrolled heart disease or high blood pressure.
  • Have active autoimmune blood disorders.
  • Have other serious medical conditions or infections that could interfere with the study.
  • Have severe lung disease or nerve damage.
  • Have another active cancer or a history of cancer within the last 3 years, except for certain skin or localized cancers.
  • Are pregnant or breastfeeding.
  • Have active infections like HIV, hepatitis B, or hepatitis C, unless under control.
  • Have impaired decision-making ability.
  • Have had major surgery within 4 weeks before starting the study.
  • Need a live vaccine within 28 days before or during the study.
  • Have allergies to any of the study drugs.
  • Are participating in another clinical trial.

Locations

FACILITYZIPCITYSTATE
University of Miami33146MiamiFlorida

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