Part 1 and Part 2 cohort 3: Patients diagnosed with AML ( bone marrow (BM) or peripheral
blood (PB) blast counts >/= 20%) and have received prior chemotherapy and/or standard of
care and have relapsed, refractory or Minimal Residual Disease (defined as patients showing
residual blast 10-14 days post-induction chemotherapy).
• Patients that are not candidates to receive standard of care and/or refusing the standard
care of therapies will also be considered.
Part 2 - Cohort 1 and 2: Newly diagnosed, previously untreated de novo or secondary AML
population (AML with bone marrow or peripheral blast counts 20%):
- Cohort 1: Fit to receive intensive remission induction chemotherapy.
- Cohort 2: Unfit to receive or not considered a candidate for intensive remission
induction chemotherapy.
Part 1 and 2:
- Life expectancy at least 12 weeks.
- Hydroxyurea is allowed on study to control total peripheral white blood cell count but
must be ceased 24 hours prior to first dose.
- Off of prior therapy for 2-4 weeks prior to first dose.
- ECOG performance status: 0 to 2.
- Resolved acute effects of any prior therapy.
- Adequate renal and hepatic function.
- Patients with acute promyelocytic leukemia, AML with known central nervous system
(CNS) involvement unless the patient has completed treatment for the CNS disease, has
recovered from the acute effects of therapy prior to study entry, and is
neurologically stable.
- Patient is known refractory to platelet or packed red cell transfusions per
institutional guidelines.
- Prior treatment with a compound targeting CXCR4.
- Chronic systemic corticosteroid treatment.
- Known or suspected hypersensitivity to recombinant human proteins.
- Chronic graft versus host disease (GVHD), active GVHD with other than Grade 1 skin
involvement, or GVHD requiring systemic immunosuppressive treatment (Part 1 and cohort
3).
- Not recovered from stem cell transplant associated toxicities (Part 1 and cohort 3).
- Prior treatment with hypomethylating agents or chemotherapy for antecedent
myelodysplastic syndrome (MDS) (Part 2, cohort 2)
- AML associated with favorable risk karyotypes, including inv(16), t(8;21), t(16;16),
or t(15;17) (cohort 2)
- Candidates for allogeneic stem cell transplant (Part 2, cohort 2)
- Known hypersensitivity to cytarabine or daunorubicin (Part 2, cohort 1) and decitabine
or azacitidine or mannitol (Part 2, cohort 2).