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Trial ID: NCT03755804
Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17
- 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
- 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.
- 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.
drug: Brentuximab Vedotin
other: Quality of Life Measurements
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