NCT00061945 — drugset

Summary

This phase I/II trial studies the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy also work in different ways to kill cancer cells or stop them from growing. Giving alemtuzumab together with combination chemotherapy may be a better way to block cancer growth.

Timeline

Start: 2003-06
Primary completion: 2007-12
Completion: 2012-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alemtuzumab	Monoclonal antibody	10 mg	Subcutaneous
Subject	Alemtuzumab	Monoclonal antibody	20 mg	Subcutaneous
Subject	Alemtuzumab	Monoclonal antibody	30 mg	Subcutaneous
Subject	Imatinib	Small molecule	—	Oral
Background	Acyclovir	Small molecule	—	Oral
Background	Allopurinol	Small molecule	—	Oral
Background	Cyclophosphamide	Other / unclassified	—	Intravenous
Background	Cytarabine	Small molecule	—	Intravenous
Background	Daunorubicin	Small molecule	—	Intravenous
Background	Dexamethasone	Small molecule	—	Oral
Background	Leucovorin	Small molecule	—	Intravenous
Background	MERCAPTOPURINE ANHYDROUS	Small molecule	—	Oral
Background	Methotrexate	Small molecule	—	Intrathecal
Background	Vincristine	Small molecule	—	Intravenous
Background	asparaginase	Protein / enzyme biologic	—	Subcutaneous
Background	filgrastim	Protein / enzyme biologic	—	Subcutaneous
Background	trimethoprim-sulfamethoxazole	Unknown	—	Oral

Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia

Summary

Timeline

Drugs

Indications