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 170 人开始时间: 2015年7月7日最近更新: 2016年3月14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 AML M3, after one prior therapy only, 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:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 125

•Patients with acute promyelocytic leukemia (AML M3), known central nervous system (CNS) leukemia, or who are in blast transformation of chronic myeloid leukemia (CML) will be excluded from this study.

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