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Recruiting NCT05980806

A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Phase II Interventional Myelofibrosis Moderate Thrombocytopenia Mild Thrombocytopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Selinexor 60 mg, Selinexor 40 mg, Ruxolitinib, Pacritinib.
Who it may be relevant to
Registry conditions: Myelofibrosis, Moderate Thrombocytopenia, Mild Thrombocytopenia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Belgium, Bulgaria, Canada, Czechia +14
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Overview

The main purpose of this study is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and with normal platelet counts or with mild to moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.

Interventions

  • Drug Selinexor 60 mg
    Participants will receive selinexor 60 mg oral tablets QW.
  • Drug Selinexor 40 mg
    Participants will receive selinexor 40 mg oral tablets QW.
  • Drug Ruxolitinib
    Participants will receive ruxolitinib per local package insert.
  • Drug Pacritinib
    Participants will receive pacritinib per local package insert. For countries where not approved, 200 mg twice daily is the starting dose.
  • Drug Momelotinib
    Participants will receive momelotinib per local package insert.

Primary outcome measures

  • Proportion of Participants with Spleen Volume Reduction ≥35% (SVR35) at Week 24 [Time frame: At Week 24]
Secondary outcome measures (2)
  • Absolute Mean Change in Total Symptom Score (Abs-TSS) from baseline to Week 24 [Time frame: At Baseline and Week 24]
  • Incidence and severity of TEAEs, including TRAEs and SAEs [Time frame: From Baseline to EoS (approximately 48 months)]

Eligibility criteria

Inclusion criteria

  • A diagnosis of MF or post-ET or post-PV MF according to the 2016 World Health Organization (WHO) classification of MPN, confirmed by the most recent local pathology report
  • Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (>=) 450 cubic square centimeter (cm\^3) by MRI or CT scan (results from MRI or CT imaging performed within 28 days prior to C1D1 are acceptable)
  • DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk
  • ECOG Performance Status less than or equal to (<=) 2
  • Platelet count of greater than or equal to (>=) 50 x 10\^9/L without platelet transfusion within 7 days prior to the first dose of selinexor
  • Absolute neutrophil count (ANC) >=1.0 × 10\^9/L without need for growth factors within 7 days prior to the first dose of selinexor
  • Adequate liver function as defined by the following: aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 × upper limit normal (ULN) and serum total bilirubin <= 3×ULN
  • Calculated creatinine clearance (CrCl) greater than (>) 15 milliliter per minute (mL/min) based on the Cockcroft and Gault formula
  • Active symptoms of MF as determined by presence of at least 2 symptoms with an average score >= 5 or total score of >= 12 at screening (at least 5 of 7 consecutive days immediately preceding C1D1) using the MFSAF V4.0
  • Must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study
  • Currently not eligible for stem cell transplantation
  • Must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50)

Exclusion criteria

  • More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)
  • Previous treatment with JAK inhibitors for MF
  • Previous treatment with selinexor or other XPO1 inhibitors
  • Females who are pregnant or lactating
  • Prior splenectomy, splenic radiation, or a splenic embolization within 6 months prior to C1D1
  • History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG), cerebrovascular accident (transient ischemic attack \[TIA\]), ventricular arrhythmias, congestive heart failure class > 2 per New York Heart Association (NYHA) within 6 months of C1D1
  • Unable to tolerate two forms of antiemetics prior to each dose for the first two cycles

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 11 centers
  • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico — Milan
  • Hematology Division, Mauriziano Hospital, University of Turin — Orbassano
  • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino — Torino
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
  • IRCCS Ospedale Policlinico San Martino — Genova
  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST — Meldola
  • Istituto Europeo di Oncologia — Milan
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda — Milan
  • … and 3 more centers
France · 8 centers
  • Institut Bergonié — Bordeaux
  • Centre Hospitalier Lyon-Sud — Pierre-Bénite
  • CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire — Tours
  • Chu De Nîmes - Institut De Cancérologie Du Gard — Nîmes
  • Centre Hospitalier Universitaire d'Angers — Angers
  • Hôpital Saint-Louis — Paris
  • Hôpital Cochin — Paris
  • Centre Hospitalier Universitaire de Saint-Etienne — Saint-Priest-en-Jarez
Spain · 8 centers
  • Hospital Germans Trias i Pujol — Badalona
  • Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar
  • Hospital Universitario Central de Asturias — Oviedo
  • Hospital San Pedro de Alcantara — Cáceres
  • Institut Català d'Oncologia Girona — Girona
  • Hospital Universitario de Gran Canaria Doctor Negrin — Las Palmas de Gran Canaria
  • Complejo Asistencial Universitario de Salamanca - Hospital Clínico — Salamanca
  • Hospital Clínico Universitario de Valencia — Valencia
United States · 7 centers
  • City of Hope - Duarte Main Site — Duarte
  • Maryland Oncology Hematology - Independent of SCRI/ US Oncology — Columbia
  • Weill Cornell Medicine NewYork-Presbyterian — New York
  • Duke University — Durham
  • Cleveland Clinic — Cleveland
  • MD Anderson — Houston
  • Huntsman Cancer Institute — Salt Lake City
Bulgaria · 5 centers
  • University Multiprofile Hospital for Active Treatment Sveti George - Base 1 — Plovdiv
  • University Hospital Sv.Ivan Rilski - Sofia — Sofia
  • University Multiprofile Hospital for Active Treatment Aleksandrovska — Sofia
  • Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia — Sofia
  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Depa — Stara Zagora
Greece · 5 centers
  • Laiko General Hospital of Athens — Athens
  • University General Hospital Attikon — Athens
  • "Georgios Papanikolaou" General Hospital of Thessaloniki — Thessaloniki
  • University General Hospital of Ioannina, Hematology Department — Ioannina
  • University General Hospital of Larissa, Hematology Department — Larissa
South Korea · 4 centers
  • Seoul St. Mary's Hospital, The Catholic University of Korea — Seocho
  • Seoul National University Hospital — Seoul
  • Severance Hospital — Seoul
  • Pusan National University Hospital — Busan
Israel · 3 centers
  • Tel Aviv Sourasky Medical Center — Tel Aviv
  • Rambam Health Care Campus — Haifa
  • Carmel Medical Center — Haifa
Poland · 3 centers
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie — Lublin
  • AIDPORT — Skórzewo
  • Medicover Clinical Integrated Systems Sp. z o.o. — Torun
Romania · 3 centers
  • Coltea - Spital Clinic — Bucharest
  • Spitalul Filantropia - Craiova — Craiova
  • Institutul Regional de Oncologie Iasi — Iași
Taiwan · 3 centers
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
  • National Taiwan University Hospital — Taipei
  • Taoyuan Chang Gung Memorial Hospital — Taoyuan
Belgium · 2 centers
  • UZ Gent — Ghent
  • UZ Leuven - Campus Gasthuisberg — Leuven
Germany · 2 centers
  • Marien Hospital Düsseldorf — Düsseldorf
  • University Hospital Jena — Jena
Canada · 1 center
  • Research Institute of the McGill University Health Centre — Montreal
Czechia · 1 center
  • Fakultní nemocnice Olomouc — Olomouc
Denmark · 1 center
  • Aarhus Universitetshospital — Aarhus N
Hungary · 1 center
  • Semmelweis Egyetem — Budapest
Netherlands · 1 center
  • Spaarne Gasthuis — Hoofddorp
United Kingdom · 1 center
  • Guy's and Saint Thomas' NHS Foundation Trust — London

Identifiers

NCT: NCT05980806 · XPORT-MF-044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗