Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

Korábbi kezelés

• Has received prior therapy for Hodgkin lymphoma

Más betegség

• 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.

Egyéb

• CD30 negative HL.
• Inadequate organ function
• Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.

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