Acute Myeloid Leukemia Clinical Trial
Official title:
A Pilot Study of CX-01 Combined With Azacitidine in the Treatment of Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia
The investigators hypothesize that CX-01 will disrupt the bone marrow microenvironment and
increase the cytotoxic effects of azacitidine on myelodysplastic syndrome (MDS) and acute
myeloid leukemia (AML) hematopoietic stem cells by disrupting the High-mobility group box
protein 1 (HMGB1) interaction with toll-like receptor 4 (TLR4) and receptors for advanced
glycation end products (RAGE), the CXC chemokine CXCL12/chemokine receptor 4 (CXCR4) axis,
and by disrupting other leukocyte and vascular adhesion molecules. In addition, CX-01 may
also help promote count recovery after treatment given its affinity for platelet factor-4
(PF4).
The selection of CX-01 dose for study in relapsed or refractory MDS and AML has been based
upon the dual requirements to have sufficient drug administered to have potential activity
but without clinically significant anticoagulation. The study dose chosen (4 mg/kg bolus
followed by 0.25 mg/kg/hour) fulfills both of these criteria. In addition, this dose is
expected to result in serum levels of CX-01 which are significantly higher than the IC90
identified in preclinical studies for inhibition of HMGB1-RAGE, toll-like receptor 2 (TLR2)
and TLR4 interaction. Therefore, the chosen dose represents a rational balance between
effective dosing and safety in thrombocytopenic patients with MDS and AML. This dose was
previously established to be safe and tolerable when combined with cytarabine and idarubicin
in patients with AML.
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