Study on BrECADD Therapy for Stage 2 B-IV Hodgkin Lymphoma
Sponsor: University of Miami
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
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami | 33146 | Miami | Florida |
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