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Monoclonal Antibodies

Immunotherapy + Chemotherapy for Hodgkin's Lymphoma

Q: Which medical centers are currently administering this clinical trial?

<p>Gibbs <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center-Pelham in Greer, <a href="https://www.withpower.com/clinical-trials/south-carolina">South carolina</a>, Penobscot Bay Medical Center in Rockport, <a href="https://www.withpower.com/clinical-trials/maine">Maine</a> and Presbyterian Hospital in Albuquerque, <a href="https://www.withpower.com/clinical-trials/new-mexico">New mexico</a> are three of the many locations hosting this clinical trial.</p>

Phase 3

Waitlist Available

Led By Alex F Herrera

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

Intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) declared at registration

Performance status corresponding to Zubrod scores of 0, 1 or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of registration to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed at 2 years

Awards & highlights

Study Summary

This trial is testing whether adding immunotherapy drugs to chemotherapy can better treat patients with newly diagnosed stage III or IV Hodgkin lymphoma.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, blood cell count changes increasing infection risk, nerve damage (neuropathy), and allergic responses due to the monoclonal antibodies nivolumab and brentuximab vedotin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am registered to receive PET radiation therapy for remaining cancer.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I can provide a sample of my tumor for testing.

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I have never had a stem cell transplant from another person.

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I do not have an inherited or acquired immune deficiency.

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I have never had lung inflammation or scarring.

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My kidney function is within the required range for the trial.

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I have a tumor that is larger than 1.5 cm.

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I haven't needed treatment for an autoimmune disease in the last 2 years.

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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

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I do not have active hepatitis B or C.

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I have been diagnosed with stage III or IV classical Hodgkin lymphoma and have not received any treatment.

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I do not have lymphoma in my brain or spinal cord.

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I have not received a live vaccine in the last 30 days.

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I have had a specific scan within the last 42 days to check my disease.

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I have not had a stem cell transplant from a donor.

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I have not had a solid organ transplant.

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I am not pregnant or nursing and had a negative pregnancy test recently.

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I have not had chemotherapy, radiation, or antibody treatment for Hodgkin lymphoma, but I may have taken steroids.

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I am 12 years old or older.

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I am 12 years old or older.

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My most recent HIV test shows an undetectable or very low viral load.

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I have not had chemotherapy, radiation, or antibody treatment for Hodgkin lymphoma.

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My nerve damage does not severely affect my daily activities.

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I have been newly diagnosed with stage III or IV Hodgkin lymphoma and have not received any treatment.

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I am under 18 and will be treated as if I intend to continue with PET RT.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of registration to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of registration to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed at 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival (PFS)

Secondary outcome measures

Event-free survival (EFS)

Incidence of adverse events

Metabolic complete response rate

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (chemotherapy, brentuximab vedotin, radiation)Experimental Treatment13 Interventions

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.

Group II: Arm I (chemotherapy, nivolumab, radiation)Experimental Treatment13 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vinblastine Sulfate

2007

Completed Phase 4

~300

Dacarbazine

2005

Completed Phase 3

~5110

Filgrastim

2000

Completed Phase 3

~3670

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Radiation Therapy

2017

Completed Phase 3

~7250

Pegfilgrastim

2013

Completed Phase 3

~4410

Biospecimen Collection

2004

Completed Phase 2

~1700

Brentuximab Vedotin

2015

Completed Phase 4

~1070

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Nivolumab

2014

Completed Phase 3

~4750

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 26Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,929,376 Total Patients Enrolled

Alex F HerreraPrincipal InvestigatorSWOG Cancer Research Network

11 Previous Clinical Trials

566 Total Patients Enrolled

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03907488 — Phase 3

Hodgkin's Lymphoma Research Study Groups: Arm I (chemotherapy, nivolumab, radiation), Arm II (chemotherapy, brentuximab vedotin, radiation)

Hodgkin's Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT03907488 — Phase 3

Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03907488 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What kind of conditions can be managed through Radiation Therapy?

"Radiation Therapy is a popular option when dealing with complete resection therapy. Additionally, this form of treatment can be successful in managing conditions such as cyclic neutropenia, acute lymphoblastic leukemia (ALL), and primary cutaneous anaplastic large cell lymphoma."

Answered by AI

Is this pioneering research that hasn't been attempted before?

"In total, 1250 ongoing studies involving Radiation Therapy are being conducted in 72 countries and 3159 cities. Alfacell's 1997 trial marked the first of its kind; it concluded Phase 3 approval with 300 participants. Since then, 1859 similar investigations have been undertaken."

Answered by AI

Are there any available openings for this clinical trial?

"Data available on clinicaltrials.gov reveals that this trial is not presently taking applicants. The initial posting of the study was July 19th 2019, and it has been updated most recently to December 2nd 2022. Although no participants are needed for this particular research project, there are 3477 other studies actively recruiting volunteers at present."

Answered by AI

How has Radiation Therapy been employed in previous medical experiments?

"Radiation Therapy was first evaluated in 1997 at Spectrum Health Hospital - Butterworth Campus, with 1859 studies already concluded. Currently, 1250 different trials are active; many of these can be found near Greer, South carolina."

Answered by AI

How many individuals are actively engaging in this investigation?

"At this time, recruitment for this medical trial has been discontinued. The study was originally posted on July 19th 2019 and last updated in December 2nd 2022. Alternately, there are currently over two thousand studies accepting patients with Hodgkin disease and more than a thousand trials recruiting participants for radiation therapy treatments."

Answered by AI

Which medical centers are currently administering this clinical trial?

"Gibbs Cancer Center-Pelham in Greer, South carolina, Penobscot Bay Medical Center in Rockport, Maine and Presbyterian Hospital in Albuquerque, New mexico are three of the many locations hosting this clinical trial."

Answered by AI

Has the FDA sanctioned Radiation Therapy for clinical use?

"The perceived safety of radiation therapy has been marked as a 3 due to the backing it receives from Phase 3 trials and multiple sources that confirm its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma

2019. "Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03907488.

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