Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥18 years
Diagnosis of chronic myeloid leukemia (CML) and cytogenetic positive for the Philadelphia chromosome (Ph+), documented Ph+ cells on bone marrow assessment (BMA) ≤6 weeks prior to treatment
Either chronic-phase CML, with \<15% blasts in peripheral blood and bone marrow, or advanced-phase CML, including Ph+ acute lymphoblastic leukemia (ALL) (\> 5% blasts) or hematologic progression with ≥15% blasts not in complete cytogenetic remission
Resistance or suboptimal response to imatinib, dasatinib, or nilotinib and no known T315I/A Abl-kinase mutation.
You may not be if
Known Abl-kinase T315I or T315A mutation
CCyR at baseline
Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Uncontrolled or significant cardiovascular disease
Grade 3 or higher peripheral blood counts
Serum calcium or phosphate below the lower limit of normal
Baseline hypomagnesemia and amylase or lipase at least Grade 1 or higher
Reduced renal function, defined as serum creatinine level \>3\*upper limit of normal
Prior therapies for CML or Ph+ ALL permitted, with the following restriction:
* Therapy permitted with corticosteroids, hydroxyurea, or anagrelide prior to starting treatment and during the first 4 weeks on study
* 6 months or longer after stem cell transplantation
* 28 days or longer after any investigational agent
* 7 days or longer after any standard chemotherapy agent
* Concomitant use of medications with a known risk of causing Torsades de Pointes
* Concomitant use of strong inhibitors of the CYP3A4 isoenzyme
