A Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML

Inclusion Criteria:

- Patients ≥ 18 years of age

- ECOG (Eastern Cooperative Oncology Group) Performance Status 0, 1, or 2

- Must have a diagnosis of Philadelphia chromosome positive (Ph+) chronic myeloid
leukemia (CML) in chronic phase, with no previous evidence of accelerated or
blast-phase disease.

- Must be actively receiving treatment for their CML with a tyrosine kinase inhibitor
(TKI): imatinib, dasatinib, nilotinib or bosutinib, and must be on stable dose for > 1
year.

- Must have an ongoing complete hematologic response (CHR) on a TKI

- Must have an ongoing complete cytogenetic response (CCyR) on a TKI

- Must be in a major molecular remission (MMR) on a TKI for a minimum of 1 year leading
up to enrollment.

- Adequate end organ function

- Adequate electrolytes

- Adequate platelet count

- Adequate neutrophil count

- Written informed consent prior to any screening procedures

Exclusion Criteria:

- Patients in complete molecular remission (CMR) on a TKI.

- Patients who have failed nilotinib or not tolerated nilotinib in the past

- Certain cardiovascular disorders

- Currently receiving treatment with strong CYP3A4 inhibitors which cannot be
discontinued prior to starting study drug

- Actively receiving herbal medicines that are strong CYP3A4 inhibitors and/or inducers
and treatment cannot be discontinued prior to starting study drug

- Currently receiving treatment with any medications that have the potential to prolong
the QT interval that cannot be discontinued prior to starting study drug

- Impaired gastrointestinal (GI) function or GI disease that may significantly alter the
absorption of the drug

- Acute or chronic pancreatic disease within the last year

- Cytopathologically confirmed Central Nervous System (CNS) infiltration

- Another primary malignancy that requires systemic chemotherapy or radiation

- Acute or chronic liver disease or severe renal disease considered unrelated to the
cancer

- History of significant congenital or acquired bleeding disorder unrelated to cancer

- Major surgery within 4 weeks prior to Day 1 of the study or who have not recovered
from prior surgery

- Past treatment with ruxolitinib

- Treatment with other investigational agent within 30 days of Day 1

- Inability to grant consent or history of non-compliance to medical regimens

- Women who are breastfeeding

- Women of child-bearing potential, unless they are using highly effective contraception