drugset
drugset / Trial / NCT00981799

Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL

NCT00981799 ↗

Phase 1/2 Terminated 23 enrolled Therapeutic Advances in Childhood Leukemia Consortium GlaxoSmithKline · collabNovartis · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.

Timeline

Start
2010-06
Primary completion
2015-11
Completion
2016-07-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 330 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 400 mg/m2 Intravenous
Subject Nelarabine Small molecule 325 mg/m2 Intravenous
Subject Nelarabine Small molecule 480 mg/m2 Intravenous
Subject Nelarabine Small molecule 650 mg/m2 Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous
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 filgrastim Protein / enzyme biologic 5 ug/kg Intravenous

Indications

T-cell acute lymphoblastic leukemia T-lymphoblastic lymphoma