ANHL12P1 Anaplastic Lymphoma Study (PRO00001704)

Full Name

A randomized Phase II Trial of Brentuximab Vedotin (SGN35, NSC# 749410), or Crizotinib (NSC# 749005, commercially labeled) in Combination with Chemotherapy for Newly Diagnosed Patients with Anaplastic Lymphoma (ALCL) IND# 117117



Anaplastic Large Cell Lymphoma (ALCL) is usually treated with a combination of different anti-cancer medicines called chemotherapy. Standard chemotherapy includes doxorubicin, prednisone and vincristine (APO) or dexamethasone, cyclophosphamide ifosfamide, etoposide, doxorubicin, methotrexate and cytarabine (ALCL99). In this study, brentuximab vedotin or crizotinib will be added to ALCL99. Brentuximab vedotin (previously known as SGN-35) has been approved by the Food and Drug Administration (FDA) for the treatment of patients with Hodgkin Lymphoma and patients with ALCL when other treatments have been tried and are no longer working. Participants will receive anti-cancer treatment on this study for 19 weeks. Most of the treatment in this study is standard therapy for people with ALCL. The addition of brentuximab vedotin or crizotinib is considered experimental. Participants will receive 5 days of chemotherapy, called the prophase. After the prophase chemotherapy, participants will be randomly assigned to receive 1 of 2 treatment plans, either Arm BV or Arm CZ. There are two exceptions to randomization. If the participant's height and weight are such that your body surface area is less than 0.9 m2, then they will be non-randomly assigned to Arm BV because crizotinib is only available in strengths which are too much medicine. If one arm is temporarily closed to enrollment, then participants will be non-randomly assigned to the other arm. Those assigned to Arm BV will receive brentuximab vedotin added to standard chemotherapy. The brentuximab vedotin will be given on Day 1 of each cycle. There are 6 cycles of chemotherapy, and each cycle is 21 days. The drugs given in each cycle are not the same. Those assigned to Arm CZ will receive crizotinib added to standard chemotherapy. There are 6 cycles, and each cycle is 21 days. The crizotinib will be given as a capsule by mouth once or twice a day for 21 days. The drugs given in each cycle are not the same.



Inclusion Criteria

Must be less than 22 years of age at the time of study enrollment

Must be newly diagnosed with histologically proven Anaplastic Large Cell Lymphoma (ALCL)

Disease must be CD30 positive

Disease must be ALK positive

Must have Stage II, III or IV disease

Must not have central nervous system disease (CNS)

Must not have had previous steroid treatment and/or radiation treatment (unless it was for the emergent management of a mediastinal mass)