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Protocol No. AHOD1331

Principal Investigator DeSantes, Kenneth

Phase III

Age Group Children

Scope National

Sponsor Type Industry; Institutional; National

Title A Randomized Phase III Study of Brentuximab vedotin (IND #117117) for Newly Diagnosed High Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents

Objective The purpose of this study is to compare the effects, good and/or bad, of standard treatment to an experimental treatment where brentuximab vedotin is added to standard treatment in newly diagnosed high-risk Hodgkin lymphoma subjects to find out which is better.

Treatment Brentuximab vedotin is a drug known as an antibody-drug conjugate (ADC). It has 2 parts-to find the cancer cell and then get rid of it. The first part is a type of antibody (a man-made version of an immune system protein) that finds and attaches to the surface of most lymphoma cells. The second part is a chemotherapy (anti-cancer) drug that stops the cancer cell from dividing (which gets rid of it). Brentuximab vedotin has been approved by the FDA for the treatment of subjects with Hodgkin lymphoma when other treatments have been tried and are no longer working. It has been shown to be well-tolerated without a lot of side effects in adults. There is very little published data about using brentuximab vedotin to treat young children and adolescents, so we do not know yet whether it is helpful. For this study, brentuximab vedotin is an experimental drug.

Description You will receive 1 of 2 different treatment plans. The treatment plan that you receive is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by computer.You will be randomized to either standard arm or experimental arm. The standard arm has 5 cycles of treatment with the following drugs: doxorubicin , bleomycin, vincristine , etoposide, prednisone and cyclophosphamide. The experimental arm has 5 cycles of treatment with the following drugs: Brentuximab vedotin, doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide. Various methods will be used to give drugs. Bentuximab Vedotin, Doxorubicin, Etoposide, Cyclophosphamide, and Vincristine are given intravenously (IV), Filgrastim is given SubQ or IV and Prednisone is given by mouth.

Key Eligibility
  • Patients must be ages greater than or equal to 2 and less than 19 years old
  • Patients with newly diagnosed, pathologically confirmed Stage IVA,Stage IVB, Stage IIB with bulk, or Stage IIIB Hodgkin Lymphoma
  • Patients with nodular lymphocyte-predominant Hodgkin Lymphoma are excluded
  • Patients with an immunodeficiency that existed prior to diagnosis are excluded
  • Patients who are pregnant are excluded
  • Lactating females who plan to breastfeed are excluded
  • Patients known to be positive for HIV are not eligible
  • Patients who have received any previous chemotherapy or radiation therapy are not eligible
  • Patients who have received corticosteroids within 28 days of enrollment are not eligible

Applicable Disease Sites Lymphoma

Therapies Involved Cytotoxic Chemotherapy; Immunotherapy

Drugs Involved Adcetris (Brentuximab); Brentuximab; adr (doxorubicin); adria (doxorubicin); adriamycin (doxorubicin); blenoxane (bleomycin); bleomycin; cpm (cyclophosphamide); ctx (cyclophosphamide); cyclophosphamide; cytoxan (cyclophosphamide); dox (doxorubicin); doxorubicin; etoposide; neosar (cyclophosphamide); oncovin (vincristine); prednisone; vcr (vincristine); vepesid (etoposide); vin (vincristine); vincristine; vp-16 (etoposide)

Status Open

Participating Institutions Gundersen Health System; UW Hospital and Clinics