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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
Adequate renal function based on GFR ≥ 70 ml/min/1.73m^2 or serum creatinine adjusted for age and gender
Adequate hepatic function (total bilirubin < 1.5 x ULN for age, and SGOT/SGPT < 2.5 x ULN for age)
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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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 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
432 Previous Clinical Trials
5,307,851 Total Patients Enrolled
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
73,921 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
~7 spots leftby May 2025
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