drugset / Trial / NCT01186328

EZN-3042 Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL)

Phase 1 Terminated 6 enrolled Therapeutic Advances in Childhood Leukemia Consortium Enzon Pharmaceuticals, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

An experimental drug called EZN-3042 targets survivin, a protein expressed in leukemia cells at relapse that promotes the leukemia cells to grow. The main goal of this phase I study is to find out the dose of EZN-3042 that can be safely given without serious side effects both alone and in combination with standard chemotherapy drugs during re-induction.

Timeline

Start: 2010-08-24
Primary completion: 2012-01-10
Completion: 2012-01-10

Publications

Results Raetz EA, Morrison D, Romanos-Sirakis E, Gaynon P, Sposto R, Bhojwani D, Bostrom BC, Brown P, Eckroth E, Cassar J, Malvar J, Buchbinder A, Carroll WL. A phase I study of EZN-3042, a novel survivin messenger ribonucleic acid (mRNA) antagonist, administered in combination with chemotherapy in children with relapsed acute lymphoblastic leukemia (ALL): a report from the therapeutic advances in childhood leukemia and lymphoma (TACL) consortium. J Pediatr Hematol Oncol. 2014 Aug;36(6):458-63. doi: 10.1097/MPH.0b013e3182a8f58f.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EZN-3042	Unknown	1.5 mg/kg	Intravenous
Subject	EZN-3042	Unknown	2.5 mg/kg	Intravenous
Subject	EZN-3042	Unknown	5 mg/kg	Intravenous
Subject	EZN-3042	Unknown	6.5 mg/kg	Intravenous
Background	Asparaginase Erwinia chrysanthemi	Protein / enzyme biologic	—	—
Background	Cytarabine	Small molecule	16 mg	Intrathecal
Background	Cytarabine	Small molecule	20 mg	Intrathecal
Background	Cytarabine	Small molecule	24 mg	Intrathecal
Background	Cytarabine	Small molecule	30 mg	Intrathecal
Background	Cytarabine	Small molecule	50 mg	Intrathecal
Background	Cytarabine	Small molecule	70 mg	Intrathecal
Background	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous
Background	Hydrocortisone	Other / unclassified	8 mg	Intrathecal
Background	Hydrocortisone	Other / unclassified	10 mg	Intrathecal
Background	Hydrocortisone	Other / unclassified	12 mg	Intrathecal
Background	Hydrocortisone	Other / unclassified	15 mg	Intrathecal
Background	Methotrexate	Small molecule	8 mg	Intrathecal
Background	Methotrexate	Small molecule	10 mg	Intrathecal
Background	Methotrexate	Small molecule	12 mg	Intrathecal
Background	Methotrexate	Small molecule	15 mg	Intrathecal
Background	Methylprednisolone	Other / unclassified	—	Intravenous
Background	Pegaspargase	Protein / enzyme biologic	2500 iu	Intramuscular
Background	Prednisone	Other / unclassified	40 mg/m2	Oral
Background	Vincristine	Small molecule	1.5 mg/m2	Intravenous

EZN-3042 Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL)

Summary

Timeline

Publications

Drugs

Indications