Protocol # :
Hodgkin Lymphoma
Disease Sites
Hodgkin's Lymphoma
Principal Investigator
Feraco, Angela, M

Trial Description

This is a phase II study using risk and response-adapted therapy for low, intermediate and
high risk classical Hodgkin lymphoma. Chemotherapy regimens will be based on risk group
assignment. Low-risk and intermediate- risk patients will be treated with bendamustine,
etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine, and
prednisone (BEABOVP) chemotherapy. High-risk patients will receive Adcetris® (brentuximab
vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) (AEPA) and cyclophosphamide,
Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC) (CAPDac) chemotherapy.
Residual node radiotherapy will be given at the end of all chemotherapy only to involved
nodes that do not have an adequate response (AR) after 2 cycles of therapy for all risk

Eligibility Requirements

Inclusion Criteria:

- Histologically confirmed, previously untreated CD30+ classical HL. (Participants are
still eligible if they received limited emergent RT or steroid therapy - maximum of 7
days if within the last month or as approved by PI).

- Age ≤ 21 years at the time of diagnosis (i.e., participants are eligible until their
22nd birthday) for low-risk and intermediate-risk

- Age ≤ 25 years at the time of diagnosis (i.e., participants are eligible until their
26th birthday) for high-risk

- All Ann Arbor stages.

- Low-Risk: IA, IIA (excluding patients with "E" lesions or mediastinal bulk)

- Intermediate-Risk: IA or IIA with "E" lesions or bulky mediastinal adenopathy
(mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)
and IB, IIIA.

- High-Risk: IIB, IIIB, IV

- Adequate renal function based on GFR ≥ 70 ml/min/1.73m2 OR serum creatinine adjusted
for age and gender as follows: Age 1 to < 2 years: maximum serum creatinine 0.6 mg/dL
for males and 0.6 mg/dL for females, Age 2 to < 6 years: maximum serum creatinine 0.8
mg/dL for males and 0.8 mg/dL for females, Age 6 to < 10 years: maximum serum
creatinine 1 mg/dL for males and 1 mg/dL for females, Age 10 to < 13 years: maximum
serum creatinine 1.2 mg/dL for males and 1.2 mg/dL for females, Age 13 to < 16 years:
maximum serum creatinine 1.5 mg/dL for males and 1.4 mg/dL for females, Age ≥16 years:
maximum serum creatinine 1.7 mg/dL for males and 1.4 mg/dL for females

- Adequate hepatic function (total bilirubin ≤ 1.5 x ULN for age, and AST/ALT ≤ 2.5 x
ULN for age).

- Adequate hematologic criteria at baseline, unless secondary to Hodgkin disease

- Absolute neutrophil count (ANC) ≥1000/µL

- Platelets ≥ 75,000/µL

- Adequate cardiac function defined as shortening fraction of ≥ 27% by echocardiogram or
MUGA, unless decreased function is due to large mediastinal mass or effusion related
to HL.

- Adequate pulmonary function defined as no evidence of dyspnea at rest, no exercise
intolerance, and a pulse oximetry > 92% on room air unless secondary to a large
mediastinal mass or effusion related to HL.

- Female participant who is post-menarchal must have a negative urine or serum pregnancy

- Female or male participant of reproductive potential must agree to use an effective
contraceptive method throughout duration of study treatment.

Exclusion Criteria:

- CD30 negative HL.

- Has received prior therapy for Hodgkin lymphoma

- Inadequate organ function

- High-risk participants with a history of ≥ grade 2 peripheral neuropathy or any active
neurologic disease that would impede the ability to assess neurologic toxicities.

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