Brentuximab for Newly Diagnosed Hodgkin Disease

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well tolerated and effective in children, adolescents and young adults with all stages of newly diagnosed Hodgkin lymphoma (HL).

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

Details

• Lead Sponsor: Mitchell Cairo
• Treatments: Brentuximab Vedotin; Doxorubicin; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• Normal Serum creatinine based on age or creatinine clearance >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range.

• Direct bilirubin < 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) <3 x ULN

• Shortening fraction >27% by echocardiogram, or

• Ejection fraction of >50% by radionuclide angiogram or echocardiogram.

• For patients age 1-16 years, Lansky score of ≥60.

• For patients > 16 years, Karnofsky score of ≥60.

• No prior Hodgkin lymphoma directed therapy is allowed except for emergent mediastinal irradiation (<1000cGy) for superior vena cava (SVC) syndrome.

Exclusion Criteria:

• Females who are pregnant (positive HCG) or lactating.

• Karnofsky <60% or Lansky <60% if less than 16 years of age.

• Age ≤1 year or >29.99 years of age.