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Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17
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 groups.PRIMARY OBJECTIVES * To evaluate the efficacy (adequate response) after 2 cycles of BEABOVP (bendamustine substitution for mechlorethamine in the original Stanford V chemotherapy backbon
Trial Eligibility
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 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. 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.
Study Info
Organization
St. Jude Children's Research Hospital
Primary Outcome
Response rate of adequate response
Interventions
Locations Recruiting
Lucile Packard Children's Hospital Stanford University
United States, California, Palo Alto
St. Jude Midwest Affiliate - Peoria
United States, Illinois, Peoria
St. Jude Affiliate Baton Rouge Clinic (Our Lady of the Lakes Regional Medical Center)
United States, Louisiana, Baton Rouge
Maine Children's Cancer Program
United States, Maine, Scarborough
Massachusetts General Hospital
United States, Massachusetts, Boston
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