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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 Two or More Tyrosine Kinase Inhibitors

Clinical Trial Details

The purpose of this study is to compare the benefits and side effects of ABL001 versus bosutinib in subjects with chronic myelogenous leukemia (CML). CML is characterized by an abnormal chromosome called the 'Philadelphia chromosome'. The Philadelphia chromosome creates an abnormal protein (BCR-ABL) that causes some white blood cells (leukemia cells) to grow. 

ABL001 is an investigational drug which has not been approved by the health authorities to date and is being developed to treat people with CML in chronic phase. Bosutinib is already approved by health authorities for your disease under the trade name Bosulif. 

If you agree to join this study, you may be treated with either ABL001 or bosutinib. You have a 2 in 3 chance of being treated with ABL001 and a 1 in 3 chance of being treated with bostinib. You will be asked to take one 40mg tablet of ABL001 two times a day or one 500mg tablet of bosutinib once a day for up to 168 weeks. 

Key Eligibility: 
  • Subject must be 18 or older 
  • Subject has diagnosis of CML-CP 
  • Subject has prior treatment with a minimum of 2 prior tyrosine kinase inhibitors 
  • Subject has failed treatment with a minimum of 2 prior tyrosine kinase inhibitors 
  • Detailed eligibility will be reviewed when you contact the study team 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Victoria Mendez
212-746-4829
vib9049@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1707018357

ClinicalTrials.gov:

NCT03106779

Sponsor:

CABL001A2301

Status

Open to Enrollment

Age Group

Adult

Sponsor