Hodgkin Lymphoma
Conditions
Brief 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).
Interventions
DRUGBrentuximab Vedotin
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
DRUGDoxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
DRUGVincristine
Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
DRUGRituximab
Days: 2 and 16 Dose: 375 mg/m2/dose.
Sponsors
Mitchell Cairo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 29 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events) | 1 year | Adverse events will be monitored each cycle to determine if there are any events related possibly, probably or definitely related to study therapy |
| To determine the response rate | 1 year | disease evaluations will be performed after the 2nd, 4th and 6th cycles. |
Countries
United States
Outcome results
None listed