Non Hodgkin Lymphoma Clinical Trial

Brentuximab for Newly Diagnosed Hodgkin Disease

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).

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT02398240

Recruitment Status:

Active, not recruiting

Sponsor:

Mitchell Cairo

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There is 1 Location for this study

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New York Medical College
Valhalla New York, 10595, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT02398240

Recruitment Status:

Active, not recruiting

Sponsor:


Mitchell Cairo

How clear is this clinincal trial information?

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