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Title:
A phase 3, multi-center, open-label, randomized study of oral ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors [CABL001A2301]
Protocol Number:
J17177
Phase:
Phase III
Physician:
B Douglas Smith
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this study is to compare the efficacy of ABL001 versus bosutinib in patients with Chronic Myeloid Leukemia in chronic phase (CML-CP) who have previously been treated with at least 2 Tyrosine Kinase Inhibitors.
Eligibility:
Patients must be over 18 years of age with CML-CP, be within range of screening laboratory values, BCR-ABL ratio equal to 1% IS at screening, 2 prior failures/ intolerances to TKI treatments, good overall performance status, adequate organ function, must have normal potassium, magnesium, and total calcium electrolyte levels, and be able to sign consent.
Treatment:
Subjects will receive either study drug (ABL001) or bosutinib in a 2:1 randomization for a maximum of 96 weeks.
Population:
Adult
Last Update
03/05/2019 05:03 AM