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Brentuximab Vedotin and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Hodgkin Lymphoma


Title A Randomized Phase III Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents
Therapeutic Area Lymphomas, Hodgkin Lymphoma
Principal Investigator Michael J. Kelly, MD
Min Age 2 Years
Max Age 18 Years
Gender Both
Contact Jennifer Truong
617-636-8885
More Information https://www.clinicaltrials.gov/show/NCT02166463

Overview

This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.

Study Details

Inclusion Criteria

  • Subjects must have newly diagnosed, pathologically confirmed diagnosed Hodgkin lymphoma
  • Must have liver function that is normal for age
  • All subjects and/or their parents or legal guardians must sign a written informed consent

Exclusion Criteria

  • Subjects with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible
  • Subjects who have received any previous chemotherapy or radiation therapy are not eligible
  • Subjects who have received  steroids  within 28 days of beginning protocol treatment are not eligible

Study Requirements

Therapy will be given over 5, 21-day cycles. Various infusions will be performed each cycle. A CT will be performed prior to Cycle 3 and after Cycle 5. A PET scan will also be performed at baseline and again at Cycle 2. A bilateral bone marrow biopsy will be taken at baseline and during Cycles 2 and 5 if the first is positive in Stage IV subjects. Finally, a complete CBC will be performed at baseline and  prior to each cycle.

There is an optional biology study that will require various biopsies and blood draws that will be taken throughout the study.

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