Brentuximab for Newly Diagnosed Hodgkin Disease



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 29
Updated:3/15/2019
Start Date:May 2015
End Date:June 2020
Contact:Jessica Hochberg, MD
Email:jessica_hochberg@nymc.edu
Phone:9145942132

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A Pilot Study of Risk Adapted Therapy Utilizing Upfront Brentuximab With Combination Chemotherapy in the Treatment of Children, Adolescents and Young Adults With Newly Diagnosed Hodgkin Lymphoma

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).


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.
We found this trial at
1
site
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
Phone: 914-594-2150
New York Medical College The College was founded in 1860 by a group of New...
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mi
from
Valhalla, NY
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