Brentuximab for Newly Diagnosed Hodgkin Disease

Study Overview
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Brief Summary
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The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well tolerated and effective in children, adolescents and young adults with all stages of newly diagnosed Hodgkin lymphoma (HL).

Official Title
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A Pilot Study of Risk Adapted Therapy Utilizing Upfront Brentuximab With Combination Chemotherapy in the Treatment of Children, Adolescents and Young Adults With Newly Diagnosed Hodgkin Lymphoma

Conditions
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Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Brentuximab Vedotin
* Drug: Doxorubicin
* Drug: Vincristine
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal Serum creatinine based on age or creatinine clearance >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range. Direct bilirubin < 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) <3 x ULN Shortening fraction >27% by echocardiogram, or Ejection fraction of >50% by radionuclide angiogram or echocardiogram. For patients age 1-16 years, Lansky score of ≥60. For patients > 16 years, Karnofsky score of ≥60. No prior Hodgkin lymphoma directed therapy is allowed except for emergent mediastinal irradiation (<1000cGy) for superior vena cava (SVC) syndrome. Exclusion Criteria: Females who are pregnant (positive HCG) or lactating. Karnofsky <60% or Lansky <60% if less than 16 years of age. Age ≤1 year or >29.99 years of age.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Risk<br>Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy | Drug: Brentuximab Vedotin<br>* Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)<br>* Other names: Adcetris;Drug: Doxorubicin<br>* Days: 1 and 15 Dose: 25 mg/m2/dose.<br>* Other names: Doxil, Adriamycin;Drug: Vincristine<br>* Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).<br>* Other names: Oncovin;|
| Experimental: Intermediate Risk<br>Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy | Drug: Brentuximab Vedotin<br>* Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)<br>* Other names: Adcetris;Drug: Doxorubicin<br>* Days: 1 and 15 Dose: 25 mg/m2/dose.<br>* Other names: Doxil, Adriamycin;Drug: Vincristine<br>* Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).<br>* Other names: Oncovin;Drug: Rituximab<br>* Days: 2 and 16 Dose: 375 mg/m2/dose.<br>* Other names: Rituxan;|
| Experimental: High Risk<br>High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy | Drug: Brentuximab Vedotin<br>* Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)<br>* Other names: Adcetris;Drug: Doxorubicin<br>* Days: 1 and 15 Dose: 25 mg/m2/dose.<br>* Other names: Doxil, Adriamycin;Drug: Vincristine<br>* Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).<br>* Other names: Oncovin;Drug: Rituximab<br>* Days: 2 and 16 Dose: 375 mg/m2/dose.<br>* Other names: Rituxan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events) | Adverse events will be monitored each cycle to determine if there are any events related possibly, probably or definitely related to study therapy | 1 year | 
| To determine the response rate | disease evaluations will be performed after the 2nd, 4th and 6th cycles. | 1 year |