Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 3 Completed 218 enrolled Children's Oncology Group National Cancer Institute (NCI) · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.

Timeline

Start: 2008-01-15
Primary completion: 2017-09-30
Completion: 2024-06-30

Publications

Loftus JP, Yahiaoui A, Brown PA, Niswander LM, Bagashev A, Wang M, Schauf A, Tannheimer S, Tasian SK. Combinatorial efficacy of entospletinib and chemotherapy in patient-derived xenograft models of infant acute lymphoblastic leukemia. Haematologica. 2021 Apr 1;106(4):1067-1078. doi: 10.3324/haematol.2019.241729.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	lestaurtinib	Small molecule	—	Oral
Background	Cyclophosphamide	Other / unclassified	—	Intravenous
Background	Cytarabine	Small molecule	—	Intravenous
Background	Daunorubicin	Small molecule	—	Intravenous
Background	Dexamethasone	Small molecule	—	Intravenous
Background	Etoposide	Small molecule	—	Intravenous
Background	Hydrocortisone	Other / unclassified	—	Intrathecal
Background	Leucovorin	Small molecule	—	Intravenous
Background	MERCAPTOPURINE ANHYDROUS	Small molecule	—	Oral
Background	Methotrexate	Small molecule	—	Intravenous
Background	Methylprednisolone	Other / unclassified	—	Intravenous
Background	Pegaspargase	Protein / enzyme biologic	—	Intramuscular
Background	Prednisone	Other / unclassified	—	Oral
Background	Vincristine	Small molecule	—	Intravenous
Background	asparaginase	Protein / enzyme biologic	—	Intravenous
Background	filgrastim	Protein / enzyme biologic	—	Intravenous

Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Summary

Timeline

Publications

Drugs

Indications