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

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000920-26-GB

Enrollment

340

Registered

2014-08-29

Start date

2014-10-29

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia (AML) MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000012984

Interventions

Product Name: Selinexor 20 mg Coated Tablets Product Code: KPT-330 Pharmaceutical Form: Coated tablet INN or Proposed INN: Selinexor CAS

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine overall survival (OS) of selinexor as compared to physician´s choice (PC) in patients = 60 years old with relapsed/refractory AML that requires treatment and are ineligible for intensive chemotherapy and/or transplantation.;Primary end point(s): Overall survival (OS) is the primary efficacy endpoint of this study.;Timepoint(s) of evaluation of this end point: The interim analysis will take place after 62 (50%) OS events.; Secondary Objective: • To determine the proportion of patients whose OS is at least 3 months (OS3.0) • To determine the complete remission rate (CRR), including complete remission with full hematologic recovery (CR), and median disease free survival (DFS) for patients who achieve CR • To determine the modified CRR (mCRR), including CR or complete remission with incomplete hematologic recovery (CRi) (including complete remission with incomplete platelet recovery (CRp) and median DFS for patients who achieve CR or CRi (including CRp) • To determine the overall response rate (ORR) and duration of overall response (DOR), including CR, CRi, morphologic luekemia-free state (MLFS), and partial remission (PR), • To determine the disease control rate (DCR) defined as ORR + stable disease for = 4 weeks (SD), and duration of DCR, • To assess the safety and tolerability of selinexor (KPT-330), as compared to physician's choice (PC). • Quality of life and patient reported outcomes (FACT-Leukemia, EQ-5D-5L) (QoL)	—

Measure

Time frame

Main Objective: To determine overall survival (OS) of selinexor as compared to physician´s choice (PC) in patients = 60 years old with relapsed/refractory AML that requires treatment and are ineligible for intensive chemotherapy and/or transplantation.;Primary end point(s): Overall survival (OS) is the primary efficacy endpoint of this study.;Timepoint(s) of evaluation of this end point: The interim analysis will take place after 62 (50%) OS events.; Secondary Objective: • To determine the proportion of patients whose OS is at least 3 months (OS3.0) • To determine the complete remission rate (CRR), including complete remission with full hematologic recovery (CR), and median disease free survival (DFS) for patients who achieve CR • To determine the modified CRR (mCRR), including CR or complete remission with incomplete hematologic recovery (CRi) (including complete remission with incomplete platelet recovery (CRp) and median DFS for patients who achieve CR or CRi (including CRp) • To determine the overall response rate (ORR) and duration of overall response (DOR), including CR, CRi, morphologic luekemia-free state (MLFS), and partial remission (PR), • To determine the disease control rate (DCR) defined as ORR + stable disease for = 4 weeks (SD), and duration of DCR, • To assess the safety and tolerability of selinexor (KPT-330), as compared to physician's choice (PC). • Quality of life and patient reported outcomes (FACT-Leukemia, EQ-5D-5L) (QoL)

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Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoints will include the following, assessed in hierarchical fashion in the order presented below: • The proportion of patients whose OS is at least 3 months (OS3.0), • The complete remission rate (CRR) including complete remission with full hematologic recovery (CR), and median disease free survival (DFS), for patients who achieve CR, • The modified CRR (mCRR), including CR or CRi (including CRp) and median DFS for patients who achieve CR or CRi (including CRp), • The overall response rate (ORR) and duration of overall response (DOR), including CR, CRi, MLFS, and partial remission (PR), • The disease control rate (DCR) defined as ORR + stable disease for = 4 weeks (SD), and duration of DCR, • Quality of life and patient reported outcomes (FACT-Leukemia and EQ-5D-5L) (QoL) ;Timepoint(s) of evaluation of this end point: At end of study.	—

Measure

Time frame

Secondary end point(s): Secondary efficacy endpoints will include the following, assessed in hierarchical fashion in the order presented below: • The proportion of patients whose OS is at least 3 months (OS3.0), • The complete remission rate (CRR) including complete remission with full hematologic recovery (CR), and median disease free survival (DFS), for patients who achieve CR, • The modified CRR (mCRR), including CR or CRi (including CRp) and median DFS for patients who achieve CR or CRi (including CRp), • The overall response rate (ORR) and duration of overall response (DOR), including CR, CRi, MLFS, and partial remission (PR), • The disease control rate (DCR) defined as ORR + stable disease for = 4 weeks (SD), and duration of DCR, • Quality of life and patient reported outcomes (FACT-Leukemia and EQ-5D-5L) (QoL) ;Timepoint(s) of evaluation of this end point: At end of study.

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Countries

Belgium, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, United Kingdom, United States

Contacts

Public ContactClinical Trial Information Desk

Karyopharm Therapeutics, Inc.

clinicaltrials@karyopharm.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026