Nivolumab + AVD for Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a combination of drugs, nivolumab and AVD (a mix of chemotherapy medications), can effectively control a specific type of early-stage Hodgkin's lymphoma. Researchers will also assess the safety of this treatment mix. It targets children, teens, and young adults diagnosed with early-stage classical Hodgkin lymphoma that hasn't spread much (non-bulky). Participants should not have received prior systemic therapy for lymphoma, except for certain steroids for inflammation. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you should avoid using strong inhibitors or inducers of certain enzymes (CYP1A2 and CYP3A4) and immunosuppressive medications within 14 days before starting the trial. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the combination of nivolumab and AVD is generally well-tolerated by patients with Hodgkin's lymphoma. Studies have found that this treatment not only helps patients live longer but also maintains a good safety record. For example, one study reported that 94% of patients did not experience cancer progression within a year, indicating effective treatment without major safety issues.
While some side effects occurred, they were mostly manageable. Common side effects included tiredness, nausea, and low blood counts. These side effects are typical for cancer treatments and were not unusually severe for most patients. Overall, the nivolumab and AVD combination offers a promising mix of effectiveness and safety for treating Hodgkin's lymphoma.12345Why are researchers excited about this study treatment for Hodgkin's Lymphoma?
Researchers are excited about the combination of Nivolumab with AVD for treating Hodgkin's Lymphoma because Nivolumab introduces a novel mechanism of action. Unlike traditional chemotherapy that targets rapidly dividing cells, Nivolumab is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells by blocking the PD-1 pathway. This approach can potentially enhance the effectiveness of the standard AVD chemotherapy regimen, offering a more targeted attack on cancer and possibly reducing side effects. This innovative combination aims to improve patient outcomes and offer a more personalized treatment option.
What evidence suggests that nivolumab plus AVD might be an effective treatment for Hodgkin's Lymphoma?
Research has shown that using nivolumab with AVD holds great promise for treating Hodgkin's lymphoma. In one study, 91% of patients did not experience disease progression over three years. Another study found that 88% of patients remained free from disease progression over two years, marking one of the best outcomes reported. This combination also increased the rate of patients staying free from disease-related events to 90% compared to other treatments. These results suggest that this treatment could effectively control the disease. Participants in this trial will receive the combination of nivolumab and AVD to further evaluate its effectiveness.26789
Who Is on the Research Team?
David McCall, MD
Principal Investigator
UT MD Anderson
Are You a Good Fit for This Trial?
This trial is for children, teens, and young adults (ages 2–21) who have just been diagnosed with early-stage (I/II), non-bulky classical Hodgkin lymphoma. Participants need to have good heart, liver, and kidney function and be able to handle daily activities. Women of childbearing age must use birth control.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nivolumab plus AVD on an inpatient and outpatient basis. Participants will be admitted for day 1 of chemotherapy for cycle 1 and evaluated for 1 or more days following chemotherapy as needed.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and overall response rate.
What Are the Treatments Tested in This Trial?
Interventions
- AVD
- Nivolumab
Trial Overview
The study is testing a combination of four drugs—nivolumab plus AVD (doxorubicin, vinblastine, dacarbazine)—to see if they help control Hodgkin lymphoma in young patients. The safety of this drug mix will also be closely monitored.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Treatment will be administered on an inpatient and outpatient basis. Participants will be admitted for day 1 of chemotherapy for cycle 1 and evaluated for 1 or more days following chemotherapy as needed for tumor lysis or supportive care needs as directed by standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
1.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/7140/551243/Efficacy-and-safety-of-nivolumab-based-therapiesEfficacy and safety of nivolumab-based therapies in first-line ...
Despite this, the comparative efficacy and safety profiles of these combination therapies remain unclear. This meta-analysis synthesizes data ...
A real-world analysis of safety and outcomes with first line ...
Nivolumab was discontinued in 10% and all therapy in 3.7% due to toxicity. Any AE and any grade 3 or higher AE (>G3) were observed in 92% and 62%, respectively.
3.
targetedonc.com
targetedonc.com/view/durable-3-year-superiority-of-n-avd-in-advanced-hodgkin-lymphomaDurable 3-Year Superiority of N-AVD in Advanced Hodgkin ...
The 3-year data confirms that N-AVD significantly prolongs progression-free survival (PFS) compared to BV-AVD: ... The PFS benefit remained ...
Nivolumab in combination with AVD as frontline treatment for ...
With a longer follow‐up of 3.1 years, the 3‐year PFS of NAVD was durable at 91% compared to 82% in the BV‐AVD arm. , Immune‐related adverse events (irAEs) were ...
5.
cancer.gov
cancer.gov/news-events/cancer-currents-blog/2024/hodgkin-lymphoma-nivolumab-avd-first-lineNivolumab and AVD the New Standard in Hodgkin ...
The 2-year progression-free survival rate of 88% among those in this age group treated with nivolumab–AVD “is probably the best ever reported,” ...
6.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/1841/549584/A-real-world-analysis-of-safety-and-outcomes-withA real-world analysis of safety and outcomes with first line ...
S1826 demonstrated a 1-year progression free survival (PFS) of 94% for NAVD compared to 86% for brentuximab vedotin-AVD, which remained durable ...
7.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/1852/551481/Real-world-clinical-outcomes-with-novel-agentReal-world clinical outcomes with novel agent combination ...
The SWOG 1826 trial demonstrated a progression-free survival (PFS) and safety benefit with frontline N-AVD (doxorubicin, vinblastine, and ...
8.
dailynews.ascopubs.org
dailynews.ascopubs.org/do/nivahl-trial-nivolumab-and-avd-show-favorable-long-term-safety-and-efficacy-early-stageNIVAHL Trial: Nivolumab and AVD Show Favorable Long- ...
A first-line treatment regimen of nivolumab plus doxorubicin, vinblastine, and dacarbazine (AVD) was associated with consistent favorable survival and safety
9.
empr.com
empr.com/reports/nivolumab-plus-avd-shows-pfs-benefit-in-advanced-classic-hodgkin-lymphoma/Nivolumab Plus AVD Shows PFS Benefit in Advanced ...
The overall survival (OS) rates at 3 years were 98% for the N-AVD group and 97% for the BV-AVD group (HR, 0.48; 95% CI, 0.20-1.15). In the ...
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