Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

• Status: Recruiting
• Trial end date: 2028-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborators: Seagen Inc.; Seattle Genetics, Inc.; Teva Pharmaceuticals USA
• Treatments: Antibodies, Monoclonal; Bendamustine Hydrochloride; Bleomycin; Brentuximab Vedotin; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Etoposide phosphate; Imidazole; Lenograstim; Liposomal doxorubicin; Prednisolone; Prednisone; Vinblastine; Vincristine

Criteria

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.