A Randomized Phase II Trial of Brentuximab Vedotin (SGN35, NSC# 749710), or Crizotinib (NSC#749005, commercially labeled) in Combination with Chemotherapy for Newly Diagnosed Patients with Anaplastic Large Cell Lymphoma (ALCL) IND # 117117 (CTMS 16-0059)
1.1 Primary Aims
- To determine the tolerability of brentuximab vedotin given in combination with standard chemotherapy (ALCL99) and to determine the tolerability of crizotinib given in combination with chemotherapy (ALCL99).
1.1.2 Event Free Survival
-To estimate the Event Free Survival (EFS) of Arm BV and Arm CZ and contrast these to historical control data.
1.2 Secondary Aim
- To determine the prognostic significance of minimal disseminated disease (MDD) at diagnosis and minimal residual disease (MRD) as measured by RT- polymerase chain reaction (PCR) in peripheral blood.