NCT01979536 — drugset

Summary

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. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in targeted way and delivers vedotin to kill them. 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, by stopping them from dividing, or by stopping them from spreading. 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.

Timeline

Start: 2013-11-13
Primary completion: 2021-03-31
Completion: 2024-03-31

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brentuximab Vedotin	Monoclonal antibody	1.8 mg	Intravenous
Subject	Crizotinib	Small molecule	165 mg/m2	Oral
Background	Cyclophosphamide	Other / unclassified	—	Intravenous
Background	Cytarabine	Small molecule	—	Intrathecal
Background	Dexamethasone	Small molecule	—	Oral
Background	Doxorubicin	Other / unclassified	—	Intravenous
Background	Etoposide	Small molecule	—	Intravenous
Background	Ifosfamide	Small molecule	—	Intravenous
Background	Methotrexate	Small molecule	—	Intrathecal

Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma

Summary

Timeline

Publications

Drugs

Indications