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.

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-study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41919

Enrollment

Registered

2014-06-15

Start date

2015-03-08

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

acute myeloid leukemia form of blood cancer

Interventions

Study assessments: sign informed consent, demographics, full ophthalmological and visual acuity examination, 12-lead ECG, concomitant medication assessments, chest radiograph, disease risk assessmen

Eligibility

Age

18 Years to 99 Years

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.

Exclusion criteria

Exclusion criteria: Patients with 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 LeukemiaNet (ELN) disease risk assessment will be excluded from this study.

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoint: Overall survival.	—

Secondary

Measure	Time frame
* 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) The safety and tolerability of selinexor and PC will be evaluated by means of drug-related AE reports, physical examinations, and laboratory safety evaluations.	—

Measure

Time frame

* 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) The safety and tolerability of selinexor and PC will be evaluated by means of drug-related AE reports, physical examinations, and laboratory safety evaluations.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)