A Randomized, Open Label, Phase 2 Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) versus Specified Physician’s Choice in Patients = 60 Years Old with Relapsed/Refractory Acute Myeloid Leukemia (AML) Who are Ineligible for Intensive Chemotherapy and/or Transplantation. - SOPRA (Selinexor in Older Patients with Relapsed AML)

KARYOPHARM THERAPEUTICS, INC.0 个研究点目标入组 340 人开始时间: 2018年2月22日最近更新: 2018年2月26日

试验速览

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•Patients age = 60 years with relapsed/refractory AML (defined using WHO criteria) of any type except for acute promyelocytic leukemia (APL; AML M3), who have poor prognosis (intermediate or adverse risk) cytogenetics, with relapsed or refractory AML, after at least two prior AML therapies (i.e. at least one regimen including cytarabine and at least one regimen including an adequate trial of a hypomethylating agent with at least 2 cycles), who have never undergone, and who are not currently eligible for, stem cell transplantation and are currently deemed unfit for intensive chemotherapy.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 265

•Patients with acute promyelocytic leukemia (AML M3), known central nervous system (CNS) leukemia, who are in blast transformation of chronic myeloid leukemia (CML), or whose AML is classified as favorable according to the European Leukemia Net (ELN)

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