drugset
drugset / Trial / NCT00439296

ABT-751 With Chemotherapy for Relapsed Pediatric ALL

NCT00439296 ↗

Phase 1/2 Terminated 9 enrolled Therapeutic Advances in Childhood Leukemia Consortium Abbott · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study.

Timeline

Start
2006-05-22
Primary completion
2009-05-19
Completion
2009-09-23

Drugs

EvaluationDrugModalityDoseRoute
Subject ABT-751 Other / unclassified 50 mg/m2 Oral
Subject ABT-751 Other / unclassified 65 mg/m2 Oral
Subject ABT-751 Other / unclassified 80 mg/m2 Oral
Subject ABT-751 Other / unclassified 100 mg/m2 Oral
Subject ABT-751 Other / unclassified 125 mg/m2 Oral
Subject ABT-751 Other / unclassified 150 mg/m2 Oral
Subject ABT-751 Other / unclassified 175 mg/m2 Oral
Background Cyclophosphamide Other / unclassified 1000 mg/m2 Intravenous
Background Cytarabine Small molecule 30 mg Intrathecal
Background Cytarabine Small molecule 50 mg Intrathecal
Background Cytarabine Small molecule 70 mg Intrathecal
Background Cytarabine Small molecule 75 mg/m2 Intrathecal
Background Dexamethasone Small molecule 10 mg/m2 Oral
Background Doxorubicin Other / unclassified 60 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 Pegaspargase Protein / enzyme biologic 2500 iu Intramuscular
Background Thioguanine Small molecule 60 mg/m2 Oral

Indications

childhood acute lymphoblastic leukemia