What is the purpose of this study?
This partially randomized phase II trial studies
how well brentuximab vedotin or crizotinib and combination chemotherapy works
in treating patients with newly diagnosed stage II-IV anaplastic large cell
lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can
block cancer growth in different ways by targeting certain cells. Crizotinib
and methotrexate may stop the growth of cancer cells by blocking some of the
enzymes needed for cell growth. Drugs used in chemotherapy work in different
ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. It is not yet known whether brentuximab vedotin
and combination chemotherapy is more effective than crizotinib and combination
chemotherapy in treating anaplastic large cell lymphoma.
determine the tolerability of brentuximab vedotin given in combination
with standard chemotherapy (anaplastic large cell lymphoma [ALCL]99) and
to determine the tolerability of crizotinib given in combination with
estimate the event free survival (EFS) of Arm brentuximab vedotin (BV) and
Arm crizotinib (CZ) and contrast these to historical control data.
- To determine the prognostic significance of minimal
disseminated disease (MDD) at diagnosis and minimal residual disease (MRD)
as measured by real-time (RT)-polymerase chain reaction (PCR) in