Study on Brentuximab Vedotin and Nivolumab for Early Stage Classic Hodgkin Lymphoma
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT03712202
This clinical trial is exploring how well the combination of brentuximab vedotin and nivolumab works in treating patients with early stage classic Hodgkin lymphoma. These drugs aim to target and kill cancer cells and help the immune system fight the cancer.
Patient Parameters
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Program Overview
This study is testing the effectiveness of two drugs, brentuximab vedotin and nivolumab, in treating patients with stage I-II classic Hodgkin lymphoma. Brentuximab vedotin is designed to attach to cancer cells and deliver a toxic agent to kill them. Nivolumab is an immunotherapy drug that may help the immune system attack cancer cells and prevent them from growing and spreading.
Description
The main goal of this study is to determine how many patients remain free of cancer progression 18 months after treatment, based on their response to PET/CT scans. The study also aims to assess the safety, tolerability, and quality of life for patients receiving the treatment. Researchers will evaluate the effectiveness of the treatment by measuring the rate of negative PET/CT scans after initial chemotherapy cycles and by tracking patient survival over three years. Additionally, the study will explore whether certain immune responses or DNA markers in the blood can predict treatment success.
Patients are divided into two groups based on their PET/CT scan results:
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Group I (PET/CT-2 Negative): Patients without bulky disease are randomly assigned to either Arm A or B, while those with bulky disease are assigned to Arm B.
- Arm A: Patients receive brentuximab vedotin and nivolumab intravenously every 21 days for up to 3 cycles, unless the disease progresses or side effects become unacceptable.
- Arm B: Patients receive a combination of chemotherapy drugs (doxorubicin, bleomycin, vinblastine, dacarbazine) every 28 days for up to 2 cycles, followed by nivolumab every 14 days for up to 6 cycles, unless the disease progresses or side effects become unacceptable.
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Group II (PET/CT-2 Positive): Patients receive a combination of chemotherapy drugs and brentuximab vedotin every 28 days for up to 4 cycles. If their PET/CT scans become negative, they receive nivolumab every 14 days for up to 6 cycles, unless the disease progresses or side effects become unacceptable.
After completing the study treatment, patients will have follow-up visits every 6 months for 3 years.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent to participate.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Have a confirmed diagnosis of classic Hodgkin lymphoma (cHL) at an early stage (IA, IB, IIA, or IIB).
- Must have at least one tumor larger than 1.5 cm that can be measured on scans and shows activity on PET scans.
- Must have received up to 2 cycles of standard chemotherapy (ABVD) before joining the study.
Exclusion Criteria
- Have received any prior treatment for Hodgkin lymphoma, except for up to 2 cycles of ABVD.
- Have severe nerve damage or any motor nerve damage.
- Have another cancer that has not been in remission for at least 3 years, except for certain skin or prostate cancers.
- Have known brain or spinal cord disease.
- Have a history of certain severe brain or heart conditions.
- Have uncontrolled heart disease or severe heart problems.
- Have allergies to the study drugs or their components.
- Have active infections with hepatitis B, hepatitis C, or HIV, unless well-controlled.
- Have active lung inflammation or autoimmune diseases, except for certain stable conditions.
- Are pregnant or breastfeeding.
- Have any condition that would make participation unsafe or difficult according to the investigator's judgment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| City of Hope Medical Center | 91010 | Duarte | California |
| University of California San Diego | 92103 | San Diego | California |
| Emory University Hospital/Winship Cancer Institute | 30322 | Atlanta | Georgia |
| Northwestern University | 60611 | Chicago | Illinois |
| University of Chicago Comprehensive Cancer Center | 60637 | Chicago | Illinois |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Massachusetts General Hospital | 02129 | Charlestown | Massachusetts |
| Hackensack University Medical Center | 07601 | Hackensack | New Jersey |
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