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Monoclonal Antibodies
Brentuximab Vedotin + Nivolumab for Hodgkin's Lymphoma
Phase 3
Recruiting
Led By Tara O Henderson
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 12 years
Awards & highlights
Study Summary
This trial compares adding immunotherapy to standard chemo/radiation for Hodgkin lymphoma to improve survival.
Who is the study for?
This trial is for patients aged 5-60 with newly diagnosed, untreated classical Hodgkin lymphoma stages I or II. They must have proper kidney and liver function, no severe lung conditions, not be on high-dose steroids or immunosuppressants, and not have other active serious illnesses. Pregnant women and those who haven't agreed to use effective contraception are excluded.Check my eligibility
What is being tested?
The study compares standard chemotherapy (with drugs like doxorubicin and prednisone) plus radiation against the same treatment combined with immunotherapy drugs Brentuximab Vedotin and Nivolumab. The goal is to see if adding these two drugs improves survival rates.See study design
What are the potential side effects?
Possible side effects include immune system reactions, infusion-related responses, fatigue, nausea, hair loss from chemo; Brentuximab may cause nerve damage; Nivolumab can lead to inflammation in organs like lungs or intestines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed up to 12 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 12 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PFS in slow-early responder (SER) patients
Progression-free survival (PFS) in rapid early responder (RER) patients
Secondary outcome measures
Contribution of SDOH to OS by race/ethnicity
Contribution of SDOH to PFS by race/ethnicity
Contribution of social determinants of health (SDOH) to initial response to therapy by race/ethnicity
+15 moreOther outcome measures
Agreement between AI derived FDG-PET measurement extraction and physician-based manual quantitative PET measurement
Association between FDG PET parameters obtained by automated measurements and PFS
Association between self-reported race/ethnicity and dimensional SDOH
+5 moreTrial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Arm H (ABVD, brentuximab vedotin, nivolumab, ISRT)Experimental Treatment13 Interventions
Patients receive treatment and imaging, and may undergo blood sample collection as in arm D.
Group II: Arm G (ABVD, eBEACOPP, ISRT)Experimental Treatment18 Interventions
Patients receive treatment and imaging, and may undergo blood sample collection as in arm C.
Group III: Arm F (ABVD, brentuximab vedotin, nivolumab)Experimental Treatment12 Interventions
Patients receive treatment as in arm B. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Group IV: Arm E (ABVD, AVD)Experimental Treatment10 Interventions
Patients receive AVD regimen (doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV) on days 1 and 15 of each treatment cycle. Each cycle lasts 28 days. Treatment continues for 4 cycles. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Group V: Arm D (ABVD, brentuximab vedotin, nivolumab, ISRT)Experimental Treatment13 Interventions
Patients receive brentuximab vedotin IV and nivolumab IV as in arm B followed by ISRT. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Group VI: Arm C (ABVD, eBEACOPP, ISRT)Experimental Treatment18 Interventions
Patients receive eBEACOPP regimen (doxorubicin hydrochloride IV on day 1, cyclophosphamide IV on day 1, etoposide or etoposide phosphate IV on days 1-3, prednisone or prednisolone orally [PO] daily for the first 14 days of each treatment cycle, procarbazine hydrochloride PO on days 1-7, bleomycin sulfate IV on day 8, and vincristine sulfate IV) on day 8 of each treatment cycle. Treatment continues for 2 cycles. Each cycle lasts 21 days. Subsequently, patients undergo ISRT. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Group VII: Arm B (ABVD, brentuximab vedotin, nivolumab)Experimental Treatment12 Interventions
Patients receive brentuximab vedotin IV and nivolumab IV once during each treatment cycle. Each cycle lasts 21 days. Treatment continues for 4 cycles. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Group VIII: Arm A (ABVD)Active Control10 Interventions
Patients receive ABVD IV for an additional 2 cycles on study. Each cycle lasts 28 days and ABVD is administered on days 1 and 15 of each cycle. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo blood sample collection on trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Cyclophosphamide
1995
Completed Phase 3
~3770
Dacarbazine
2005
Completed Phase 3
~5110
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Etoposide
2010
Completed Phase 3
~2440
Etoposide Phosphate
2011
Completed Phase 2
~160
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Nivolumab
2014
Completed Phase 3
~4750
Positron Emission Tomography
2008
Completed Phase 2
~2240
Prednisolone
2005
Completed Phase 4
~2720
Prednisone
2014
Completed Phase 4
~2370
Procarbazine Hydrochloride
2010
Completed Phase 2
~170
Vinblastine Sulfate
2007
Completed Phase 4
~300
Vincristine Sulfate
2005
Completed Phase 3
~10150
Biospecimen Collection
2004
Completed Phase 2
~1700
Bleomycin Sulfate
2010
Completed Phase 3
~1960
Brentuximab Vedotin
2015
Completed Phase 4
~1070
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,923,979 Total Patients Enrolled
Tara O HendersonPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
376 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a weak immune system that is not well-managed.I am 17 or younger with a moderate ability to carry out daily activities.I am between 5 and 60 years old.I have a tumor that is at least 1.5 cm large.I haven't taken steroids or immunosuppressants in the last 14 days.I have received chemotherapy, radiation, or antibody treatment for Hodgkin lymphoma.I have had a solid organ or stem cell transplant.My kidneys work well enough (creatinine clearance >= 30 mL/min).I have been newly diagnosed with early-stage classic Hodgkin lymphoma.I do not have other cancers that could affect this treatment's safety or results.I have nodular lymphocyte predominant Hodgkin lymphoma.I have not received a live vaccine in the last 30 days.I am a child (5-17) with a chest X-ray or an adult with a chest X-ray/CT scan.I am 18 or older and can take care of myself, with varying levels of assistance.I am HIV-positive, on treatment, and my viral load is undetectable.I have had active lung inflammation or disease in the past.I had a PET scan within the last 42 days.My lung function test shows I can breathe well enough.My child's kidney function tests are within the required range for their age and gender.My hepatitis B is under control with treatment, or I was treated and cured of hepatitis C.I do not have severe nerve damage or Charcot-Marie-Tooth disease.I am sexually active and not using effective birth control.
Research Study Groups:
This trial has the following groups:- Group 1: Arm G (ABVD, eBEACOPP, ISRT)
- Group 2: Arm A (ABVD)
- Group 3: Arm B (ABVD, brentuximab vedotin, nivolumab)
- Group 4: Arm C (ABVD, eBEACOPP, ISRT)
- Group 5: Arm D (ABVD, brentuximab vedotin, nivolumab, ISRT)
- Group 6: Arm E (ABVD, AVD)
- Group 7: Arm F (ABVD, brentuximab vedotin, nivolumab)
- Group 8: Arm H (ABVD, brentuximab vedotin, nivolumab, ISRT)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what quantity of locations is this examination being conducted?
"The trial is currently running out of Ochsner Medical Center Jefferson in New Orleans, Louisiana, Roswell Park Cancer Institute in Buffalo, New york and NYU Winthrop Hospital in Mineola Rhode island amongst 7 other medical centres."
Answered by AI
How many participants are there in this trial?
"This medical study necessitates the participation of 1875 people who fit its criteria. Potential participants can come from two of our major sites, namely Ochsner Medical Center Jefferson in New Orleans and Roswell Park Cancer Institute in Buffalo."
Answered by AI
Do the age limitations for this research project preclude those over 69 years of age?
"This study seeks to recruit participants aged 5 and 60. There are 311 trials available for minors, while seniors have access to 1547 clinical studies."
Answered by AI
Is participation in this clinical research still feasible for individuals?
"Affirmative, clinicaltrials.gov states that this study remains open for participants to enroll in. It was inaugurated on April 28th of 2023 and its information has been recently updated on May 12th of the same year. 1,875 people can apply at seven different sites."
Answered by AI
Who meets the criteria for participating in this research endeavor?
"Eligibility for this trial requires individuals to be between the ages of 5 and 60, with a diagnosis of Hodgkin's lymphoma. At present, approximately 1875 patients are being recruited."
Answered by AI
Is there an inherent danger to utilizing the Arm B (ABVD, brentuximab vedotin, nivolumab) regimen?
"Our team at Power gave Arm B (ABVD, brentuximab vedotin, nivolumab) a score of 3 due to the multiple trials that provided evidence for its efficacy and safety."
Answered by AI
Who else is applying?
What site did they apply to?
Sinai Hospital of Baltimore
What portion of applicants met pre-screening criteria?
Did not meet criteria
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