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Monoclonal Antibodies

Brentuximab + Chemotherapy + Radiation for Hodgkin Lymphoma

Phase 2

Waitlist Available

Led By Monika Metzger, MD, MSc

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)

Must not have

Has received prior therapy for Hodgkin lymphoma, except as noted above

Inability or unwillingness of research participant or legal guardian / representative to give written informed consent

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated for Hodgkin lymphoma.

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I am unable or unwilling to give my consent to participate.

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My Hodgkin's lymphoma does not express CD30.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

radiation therapy

1994

Completed Phase 3

~13390

cyclophosphamide

1994

Completed Phase 3

~8140