A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Summary

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Timeline

Start

2009-03-20

Primary completion

2016-09-01

Completion

2025-01-27

Outcome

Met primary endpoint

paper Major cytogenetic response > 30% was reached by 3 months in the imatinib-resistant/intolerant group PMID 29498925 ↗

paper CCyR > 55% was reached by 6 months in the newly diagnosed CML-CP group. PMID 29498925 ↗

paper Target responses to first- or second-line dasatinib were met early PMID 29498925 ↗

release “CA180-226 trial, at minimum two-year follow-up, patients with CP-CML resistant to or intolerant of imatinib who received Sprycel demonstrated a cumulative major cytogenetic response” bms.com ↗

Publications

• Gore L, Kearns PR, de Martino ML, Lee, De Souza CA, Bertrand Y, Hijiya N, Stork LC, Chung NG, Cardos RC, Saikia T, Fagioli F, Seo JJ, Landman-Parker J, Lancaster D, Place AE, Rabin KR, Sacchi M, Swanink R, Zwaan CM. Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Phase II Trial. J Clin Oncol. 2018 May 1;36(13):1330-1338. doi: 10.1200/JCO.2017.75.9597. Epub 2018 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	dasatinib anhydrous	Small molecule	60 mg/m2	Oral
Subject	dasatinib anhydrous	Small molecule	72 mg/m2	Oral
Subject	dasatinib anhydrous	Small molecule	80 mg/m2	Oral
Subject	dasatinib anhydrous	Small molecule	96 mg/m2	Oral

Indications