Selinexor (KPT-330) in Older Patients With Relapsed AM

Phase 1

• Conditions: Acute Myeloid Leukemia (AML); MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000012984; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000920-26-GB
• Lead Sponsor: Karyopharm Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-29
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 340

Inclusion Criteria

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 one prior AML therapy (must have included 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:
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

Exclusion Criteria

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) disease risk assessment will be excluded from this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified