drugset / Trial / NCT01004497

First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Ph-Positive ALL

NCT01004497

Phase 2 Completed 51 enrolled The Catholic University of Korea
NaSingle-groupOpen-labelTreatment

Summary

The main aim of the present study is to evaluate the clinical efficacy of first-line dasatinib plus conventional chemotherapy for newly diagnosed Ph-positive acute lymphoblastic leukemia. In this study, the investigators will analyze the clinical outcomes for entire patient population as well as those for transplants, respectively. In addition, the results of this study will be compared to those of the investigators current study (imatinib plus conventional chemotherapy). The safety of this treatment will also be studied.

Timeline

Start
2010-03
Primary completion
2014-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject dasatinib anhydrous Small molecule 100 mg Oral
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Background Cytarabine Small molecule 2 g Intravenous
Background Daunorubicin Small molecule 45 mg/m2 Intravenous
Background Dexamethasone Small molecule 40 mg Intravenous
Background Mitoxantrone Small molecule 12 mg/m2 Intravenous
Background Vincristine Small molecule 1.4 mg/m2 Intravenous