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Monoclonal Antibodies
Brentuximab Vedotin Combination for Hodgkin's Lymphoma
Phase 2
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants enrolling in Part B of the study must have Ann Arbor Stage I or II cHL with bulky mediastinal disease, or Stage III or IV
Participants enrolling in Part C of the study must have Ann Arbor Stage I or II cHL without bulky disease
Must not have
Nodular lymphocyte predominant HL
History of a cerebral vascular event within 6 months of the first dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33.8 months
Awards & highlights
Summary
This trial will study two treatment combinations for classical Hodgkin lymphoma (cHL). A side effect is anything the drug does besides treating cancer. This study will have three parts (Parts A, B, and C). Part A will look at whether the A+AVD drug combination reduces the number of participants who experience the side effect of febrile neutropenia. Parts B and C will use drug combination of brentuximab vedotin, plus nivolumab, doxorubicin, and dacarbazine. These four drugs are called "AN+AD."
Who is the study for?
This trial is for individuals with classical Hodgkin lymphoma (cHL) who haven't had treatment before. Participants must have specific stages of cHL as defined by the Ann Arbor classification, measurable disease, and be at least 12 years old in the US or 18 elsewhere. They should also have a performance status that allows daily activity.
What is being tested?
The trial tests two drug combinations: 'A+AVD' (brentuximab vedotin with doxorubicin, vinblastine, dacarbazine) and 'AN+AD' (brentuximab vedotin with nivolumab, doxorubicin, dacarbazine). It aims to see how well these treatments work and what side effects they cause over several cycles.
What are the potential side effects?
Potential side effects include febrile neutropenia (fever with low white blood cell count), which can be life-threatening. Other risks may involve reactions to drugs like fatigue, infection risk increase due to low immunity cells, nerve damage symptoms like numbness or tingling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Hodgkin's lymphoma is either early stage with a large tumor in my chest or is advanced.
Select...
My Hodgkin's lymphoma is in the early stages and not widespread.
Select...
My Hodgkin's lymphoma diagnosis is confirmed by tissue analysis.
Select...
My cancer can be measured in two dimensions on scans.
Select...
I can care for myself and am up and about more than 50% of my waking hours.
Select...
My cancer is at an advanced stage (Stage III or IV).
Select...
I have classic Hodgkin lymphoma and have not received any treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My condition is nodular lymphocyte predominant Hodgkin lymphoma.
Select...
I have not had a stroke or similar brain event in the last 6 months.
Select...
My cancer has spread to my brain or its coverings.
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I haven't had a severe infection in the last two weeks.
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I am not on any other cancer treatments or experimental drugs.
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I do not have active lung disease that could affect my treatment.
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I have a history of lung scarring or my lungs are less effective at exchanging gases.
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My liver function is moderately to severely impaired.
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I am experiencing graft-versus-host disease or am on immunosuppressive therapy for it.
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I have moderate to severe numbness, tingling, or muscle weakness.
Select...
I have a severe lung condition not caused by my cancer.
Select...
I have been treated with brentuximab vedotin before.
Select...
I have been treated with specific immune system targeting drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 33.8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33.8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response (CR) Rate (Parts B and C)
Febrile Neutropenia (FN) Rate (Part A)
Secondary outcome measures
Actual Dose Intensity: Brentuximab Vedotin (Part A)
Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A)
Complete Response Rate (Part A)
+11 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part C: AN+ADExperimental Treatment4 Interventions
Brentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage I or II cHL with non-bulky mediastinal disease during each treatment cycle.
Group II: Part B: AN+ADExperimental Treatment4 Interventions
Brentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage II bulky mediastinal disease and Stage III or IV cHL during each treatment cycle.
Group III: Part A: A+AVDExperimental Treatment5 Interventions
Brentuximab vedotin (A) plus doxorubicin (+A), vinblastine (V), and dacarbazine (D) administered by intravenous (IV) infusion in participants with advanced stage classical Hodgkin lymphoma (cHL) during each treatment cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
brentuximab vedotin
2010
Completed Phase 3
~1880
doxorubicin
2005
Completed Phase 3
~9130
vinblastine
2010
Completed Phase 3
~1490
dacarbazine
2008
Completed Phase 3
~6240
G-CSF
2014
Completed Phase 4
~1610
nivolumab
2016
Completed Phase 3
~4960
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,494 Total Patients Enrolled
Seagen Inc.Lead Sponsor
209 Previous Clinical Trials
74,120 Total Patients Enrolled
Linda Ho, MDStudy DirectorSeagen Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is nodular lymphocyte predominant Hodgkin lymphoma.I haven't had cancer, except for certain low-risk types, in the last 3 years.I haven't had chemotherapy, radiation, or immunotherapy in the last 4 weeks.I have not had a stroke or similar brain event in the last 6 months.My cancer has spread to my brain or its coverings.I haven't had a severe infection in the last two weeks.I am not on any other cancer treatments or experimental drugs.I do not have active lung disease that could affect my treatment.I have a history of lung scarring or my lungs are less effective at exchanging gases.My liver function is moderately to severely impaired.I am experiencing graft-versus-host disease or am on immunosuppressive therapy for it.My Hodgkin's lymphoma is either early stage with a large tumor in my chest or is advanced.My Hodgkin's lymphoma is in the early stages and not widespread.My Hodgkin's lymphoma diagnosis is confirmed by tissue analysis.My cancer can be measured in two dimensions on scans.I am at least 12 years old if in the US, or 18 if outside the US.I can care for myself and am up and about more than 50% of my waking hours.I have moderate to severe numbness, tingling, or muscle weakness.I am scheduled for additional radiotherapy to target remaining cancer cells.I have a severe lung condition not caused by my cancer.My cancer is at an advanced stage (Stage III or IV).I have been treated with brentuximab vedotin before.I have been treated with specific immune system targeting drugs.I have classic Hodgkin lymphoma and have not received any treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: A+AVD
- Group 2: Part B: AN+AD
- Group 3: Part C: AN+AD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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