Spots Global Cancer Trial Database for Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia
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Trial Identification
Brief Title: Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia
Official Title: An Investigator Sponsored Phase I/II Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia
Study ID: NCT02416908
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Washington University School of Medicine, Saint Louis, Missouri, United States
Contact Details
Name: Geoffrey Uy, M.D.
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
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