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Monoclonal Antibodies

Brentuximab + Chemotherapy + Radiation for Hodgkin Lymphoma

Phase 2
Waitlist Available
Led By Matt Ehrhardt, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed, previously untreated CD30+ classical Hodgkin Lymphoma (HL). (Participants receiving limited emergent radiation therapy (RT) or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment)
Adequate renal function based on GFR ≥ 70 ml/min/1.73m^2 or serum creatinine adjusted for age and gender
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)
Awards & highlights

Study Summary

This trial is testing a new combination of drugs and radiation therapy to treat Hodgkin lymphoma in young patients.

Who is the study for?
This trial is for young patients (up to 18 years old) with stage IIB, IIIB, or IV Hodgkin lymphoma that hasn't been treated yet. They must have a certain type of cancer cell called CD30+ and their kidneys and liver need to be working well. Girls after puberty must not be pregnant and all participants who can have children should agree to use birth control during the study.Check my eligibility
What is being tested?
The trial tests if brentuximab vedotin combined with chemotherapy drugs (etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, dacarbazine) plus radiation therapy is effective in treating Hodgkin lymphoma in youth. It looks at how these treatments work together to stop cancer from growing.See study design
What are the potential side effects?
Possible side effects include reactions where the drug enters the body, damage to blood cells leading to increased infection risk or bleeding problems, nausea or vomiting from chemotherapy drugs, hair loss, fatigue and potential long-term effects from radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Hodgkin Lymphoma that hasn't been treated yet, but I may have had emergency radiation or steroids for a short time.
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My kidney function is good based on tests.
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My liver tests are within the normal range for my age.
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I agree to use effective birth control during the study.
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I am 18 years old or younger.
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I am a woman who has started menstruating and have a negative pregnancy test.
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My cancer is at an advanced stage, but not the earliest or final stages.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).
Complete Response Rate Estimate for All Evaluable Participants
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
Secondary outcome measures
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points
Descriptive of Hematological Adverse Events
Descriptive of Infectious Adverse Events
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment9 Interventions
Participants receive AEPA regimen (brentuximab vedotin, etoposide, prednisone, doxorubicin), and CAPDac regimen (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine(R)). Filgrastim may be given as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. Some participants may volunteer to complete the quality of life assessment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
brentuximab vedotin
2010
Completed Phase 3
~1880
etoposide
1994
Completed Phase 3
~9300
prednisone
1999
Completed Phase 3
~10920
doxorubicin
2005
Completed Phase 3
~9130
cyclophosphamide
1994
Completed Phase 3
~8140
filgrastim
1997
Completed Phase 3
~7260
radiation therapy
1994
Completed Phase 3
~13390

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
427 Previous Clinical Trials
5,306,500 Total Patients Enrolled
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
69,080 Total Patients Enrolled
Matt Ehrhardt, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01920932 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Treatment
Hodgkin's Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT01920932 — Phase 2
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01920932 — Phase 2

Frequently Asked Questions

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

Are there additional studies being conducted involving brentuximab vedotin?

"At the present moment, there are 1,457 studies investigating brentuximab vedotin. Of those, 314 have reached Phase 3 of trials. The primary site for these research efforts is Bethesda in Maryland; however, 52769 different locations around the world are conducting their own investigations into this medication."

Answered by AI

To what extent are hospitals in this state administering this experiment?

"The current clinical trial is recruiting patients from Lucile Packard Children's Hospital Stanford University in Palo Alto, California, Dana-Farber Harvard Cancer Center in Boston, Massachusetts, and the Mass General Hospital Cancer Centre located in Peoria Illinois. In addition to these three sites there are an additional 6 locations involved with this study."

Answered by AI

For what clinical purposes is brentuximab vedotin commonly recommended?

"Brentuximab vedotin is a widely accepted method for treating pheochromocytomas. It has also been found to be useful in managing ulcerative colitis, varicella-zoster virus acute retinal necrosis and multiple myeloma."

Answered by AI

Is this exploration a pioneering endeavor?

"Since its first clinical trial, sponsored by Alfacell in 1997 and involving 300 patients, brentuximab vedotin has gained approval as a phase 3 drug. Currently there are 1457 active studies occurring across 3045 cities and 81 nations."

Answered by AI

Is participation in this research program available at the present moment?

"This clinical investigation is no longer recruiting individuals. It was initially posted on August 12th, 2013 and its most recent update happened on August 15th, 2022. If you are still looking for a suitable trial to enter, there are 1723 trials presently enrolling patients affected by hodgkin disease and 1457 studies relying upon brentuximab vedotin that could be of use."

Answered by AI

How many participants is the clinical trial currently accommodating?

"This research is temporarily closed, having first been posted on August 12th 2013 and last updated 8/15/2022. For those still looking to take part in a clinical trial for hodgkin disease, there are 1723 studies accepting participants at this time with 1457 trials specific to brentuximab vedotin actively recruiting patients."

Answered by AI

Has brentuximab vedotin been endorsed by the FDA?

"Brentuximab vedotin is rated a 2 on the safety scale due to its Phase 2 status. While there are reports of its safety, no studies have yet proven any efficacy from this drug."

Answered by AI
~7 spots leftby Apr 2025