Immunotherapy + Chemotherapy for Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of adding immunotherapy drugs like nivolumab or brentuximab vedotin to standard chemotherapy for treating advanced Hodgkin's lymphoma, a type of blood cancer. The goal is to determine if these combinations can shrink tumors or extend the time without symptoms returning. Participants will be divided into groups to receive different treatment combinations, which may include radiation therapy. Those newly diagnosed with stage III or IV classical Hodgkin lymphoma who have not undergone previous treatment might be suitable for this trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of promising new treatments.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients must not be on certain immunosuppressive medications or corticosteroids above a specific dose within 14 days before starting the trial. It's best to discuss your current medications with the trial team to get specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that nivolumab is generally well-tolerated by people with Hodgkin's lymphoma. One study found that many patients lived for at least five years after treatment, confirming nivolumab's safety and effectiveness for those whose Hodgkin's lymphoma has returned. Another report showed that 88% of patients did not experience disease progression for at least two years, suggesting its safety for long-term use.
For brentuximab vedotin, studies have demonstrated high response rates in patients with relapsed Hodgkin's lymphoma. Common side effects include low levels of white blood cells (neutropenia), low levels of red blood cells (anemia), and high blood sugar (hyperglycemia). However, the overall safety profile is favorable. A study indicated that more than 93% of patients were still alive six years after treatment, supporting its safe use in advanced Hodgkin's lymphoma.
Both treatments have undergone various studies and are generally well-tolerated by most patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for Hodgkin's Lymphoma because they incorporate novel immunotherapy drugs that may enhance the effectiveness of traditional chemotherapy. Unlike the standard treatment, which often involves chemotherapy alone, the investigational treatments combine chemotherapy with either nivolumab, an immunotherapy drug that boosts the immune system's ability to fight cancer, or brentuximab vedotin, an antibody-drug conjugate that directly targets cancer cells. This dual approach aims to increase the treatment's potency and potentially reduce side effects by more specifically targeting cancer cells. This innovative strategy could offer a more effective and tailored treatment option for patients battling Hodgkin's Lymphoma.
What evidence suggests that this trial's treatments could be effective for Hodgkin's Lymphoma?
Research shows that both nivolumab and brentuximab vedotin are promising treatments for advanced Hodgkin's lymphoma. In this trial, participants in Arm I will receive nivolumab with chemotherapy. Studies have found this combination results in a 92% survival rate and fewer side effects. Another study reported an 88% rate of patients living without disease progression for two years, one of the best outcomes for this condition. Participants in Arm II will receive brentuximab vedotin with chemotherapy. Brentuximab vedotin has shown strong results, with nearly 94% of some patients surviving for six years. Additionally, about 38% of patients who had no signs of cancer after treatment with brentuximab vedotin remained cancer-free for over five years. These treatments help the immune system fight cancer and deliver targeted therapy to kill cancer cells.36789
Who Is on the Research Team?
Alex F Herrera
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Eligible participants must be at least 12 years old, have measurable disease, and normal organ function. They should not be pregnant or nursing and agree to use contraception. Those with autoimmune diseases, prior malignancies (except certain treated cancers), or who received previous treatments for lymphoma are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive chemotherapy and either nivolumab or brentuximab vedotin every 28 days for 6 cycles, with optional radiation therapy after cycle 6
Radiation
Participants may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-ups every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration
What Are the Treatments Tested in This Trial?
Interventions
- Brentuximab Vedotin
- Dacarbazine
- Doxorubicin Hydrochloride
- Nivolumab
- Radiation Therapy
- Vinblastine Sulfate
Trial Overview
The study compares the effectiveness of two immunotherapy drugs—nivolumab and brentuximab vedotin—combined with chemotherapy in treating Hodgkin lymphoma. It aims to see if adding these drugs can better shrink tumors or delay symptom return compared to standard chemotherapy alone.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.
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?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Five-year survival and durability results of brentuximab ...
A total of 38% of patients who achieved CR (13 of 34) on brentuximab vedotin have remained in remission for >5 years and may be cured. Nine of the 13 patients ( ...
Overall Survival with Brentuximab Vedotin in Stage III or IV ...
The 6-year overall survival estimates were 93.9% (95% CI, 91.6 to 95.5) in the A+AVD group and 89.4% (95% CI, 86.6 to 91.7) in the ABVD group.
Real-world outcomes of brentuximab vedotin as ... - Nature
Hodgkin lymphoma (HL) has a high cure rate, with more than 80% of patients with classic HL achieving long-term remission following first-line ...
How may I benefit from ADCETRIS?
ADCETRIS was an effective treatment for classical Hodgkin lymphoma that has a high risk of coming back or getting worse after a stem cell transplant · ADCETRIS ...
5.
ashpublications.org
ashpublications.org/bloodadvances/article/7/24/7485/497552/Impact-of-cumulative-dose-of-brentuximab-vedotinImpact of cumulative dose of brentuximab vedotin on ...
Overall, disease progression occurred in 22 patients; 82% had stage IV and a median IPS of 3.5 (range, 0-6; with a median age of 32.5 years [ ...
Safety and efficacy of brentuximab vedotin in patients with ...
In phase II studies, brentuximab vedotin induced overall response rates of 75% and 86% in relapsed or refractory Hodgkin lymphoma and anaplastic large cell ...
ADCETRIS® (brentuximab vedotin) Efficacy Data - Safety Info
Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018;132:2639-2642. 4 ...
Safety and efficacy of brentuximab vedotin for Hodgkin ...
The most common adverse events ≥ grade 3 were neutropenia (24%), anemia (20%), thrombocytopenia (16%), and hyperglycemia (12%). Cytomegalovirus was detected in ...
A Multi-Center Retrospective Study on Survival and Safety
Results. Among the patients (56.1% female, median age 33.5 years), the overall treatment response rate was 76.8%. The median OS was 13.6 ...
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