Status:
ACTIVE_NOT_RECRUITING
Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Teva Pharmaceuticals USA
Seagen Inc.
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
Up to 25 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVES * To evaluate the efficacy (adequate response) after 2 cycles of BEABOVP (bendamustine substitution for mechlorethamine in the original Stanford V chemotherapy backbone) in low-ris...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2028
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT03755804
Start Date
December 12 2018
End Date
July 1 2028
Last Update
September 22 2025
Active Locations (8)
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1
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
2
St. Jude Midwest Affiliate - Peoria
Peoria, Illinois, United States, 61637
3
St. Jude Affiliate Baton Rouge Clinic (Our Lady of the Lakes Regional Medical Center)
Baton Rouge, Louisiana, United States, 70809
4
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074