Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia
Status:
Completed
Trial end date:
2019-06-21
Target enrollment:
Participant gender:
Summary
Selinexor has shown single-agent activity in a current phase I study enrolling patients with
relapsed/refractory AML with durable complete remissions (CR), complete remissions with
incomplete hematologic recovery (CRi), partial remissions (PR), and stable disease (SD)
observed. Furthermore, common toxicities included nausea, fatigue, and anorexia and were
manageable with supportive care agents. Additionally, CLAG chemotherapy has proven activity
in relapsed and refractory AML, and has been shown to be a relatively well tolerated regimen
without significant non-hematologic toxicity. Given the established role of CLAG
chemotherapy, the single agent activity of selinexor, and their non-overlapping toxicities,
the investigators propose a phase I/II open label study of selinexor in combination with CLAG
for the treatment of patients with relapsed/refractory AML.