Chemotherapy + Immunotherapy for Hodgkin's Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or medications that could interfere with the trial, you may need to stop them. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination including Brentuximab Vedotin, Doxorubicin, Vinblastine, and Dacarbazine for treating Hodgkin's Lymphoma?
Research shows that the combination of Brentuximab Vedotin with Doxorubicin, Vinblastine, and Dacarbazine (A+AVD) provides long-term benefits in progression-free survival for patients with advanced Hodgkin's Lymphoma, compared to the traditional ABVD regimen. This combination has shown potential benefits in overall survival, especially in patients with stage III or IV Hodgkin's Lymphoma.12345
Is the combination of chemotherapy drugs like doxorubicin, vinblastine, and dacarbazine safe for humans?
What makes the chemotherapy and immunotherapy drug combination unique for treating Hodgkin's Lymphoma?
This treatment combines chemotherapy drugs like doxorubicin and dacarbazine with immunotherapy drugs like nivolumab, which helps the immune system target cancer cells more effectively. Brentuximab vedotin, a key component, specifically targets CD30-positive cancer cells, which are common in Hodgkin's Lymphoma, making it a targeted approach compared to traditional chemotherapy regimens.1351112
What is the purpose of this trial?
This phase II trial evaluates how well AVD (doxorubicin, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab may improve survival of patients with stage I-II Hodgkin lymphoma.
Research Team
Steven I Park
Principal Investigator
Academic and Community Cancer Research United
Eligibility Criteria
This trial is for adults with previously untreated stage I-II non-bulky Hodgkin lymphoma. Participants must have measurable disease, adequate blood counts and organ function, no severe infections or other health conditions that could interfere with the study, not be pregnant or nursing, and agree to use contraception. Those with certain prior treatments, immunodeficiency, active hepatitis B or C, another primary malignancy within 3 years (with some exceptions), uncontrolled illnesses or known allergies to study drugs are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Participants receive doxorubicin, vinblastine, dacarbazine, and brentuximab vedotin every 28 days for 3 cycles
Consolidation Therapy
PET-positive participants receive brentuximab vedotin and nivolumab every 2 weeks for 4 cycles, followed by nivolumab alone for 8 cycles; PET-negative participants receive nivolumab every 2 weeks for 8 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Brentuximab Vedotin
- Dacarbazine
- Doxorubicin
- Nivolumab
- Vinblastine
Brentuximab Vedotin is already approved in United States, European Union for the following indications:
- Hodgkin lymphoma
- Systemic anaplastic large cell lymphoma
- Primary cutaneous anaplastic large cell lymphoma
- CD30-expressing mycosis fungoides
- Peripheral T-cell lymphoma
- Hodgkin lymphoma
- Systemic anaplastic large cell lymphoma
- Cutaneous T-cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Academic and Community Cancer Research United
Lead Sponsor
National Cancer Institute (NCI)
Collaborator