MyelofibrosisPhase 2NCT04562870
A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis
A Phase 2 study testing Selinexor and Physician's Choice Treatment in people with Myelofibrosis, run by Karyopharm Therapeutics Inc at 21 sites in 7 countries.
Trial summary
This is a Phase 2, multicenter, two-arm, open-label study to evaluate the safety and efficacy of selinexor versus treatment per physician's choice (PC) in participants with myelofibrosis (MF) who had at least 6 months of treatment with a Janus kinase (JAK)1/2 inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- Selinexor and Physician's Choice Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 17 Mar 2021to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of primary MF or post-essential thrombocythemia (ET) or post-polycythemia (PV) MF according to the 2016 World Health Organization (WHO) classification of myeloproliferative neoplasms (MPN), by the most recent local pathology report.
- Previous treatment with JAK inhibitors for at least 6 months.
- Measurable splenomegaly during the screening period as demonstrated by spleen volume of ≥450 centimeter cube (cm^3) by magnetic resonance imaging (MRI) or computerized tomography (CT) scan.
- Relapsed, Refractory or Intolerant to JAK inhibitors as defined as meeting one of the criteria below:
- less than (<) 35% spleen volume reduction by MRI or CT-scan (from baseline) or
- <50% decrease in spleen size by palpation (from baseline) or an increase of at least 3 cm with the spleen at least 5 cm below the left costal margin or
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- Spleen volume increase greater than (>) 25% from nadir or a return to within 10% of baseline after any initial response or
- Treatment with JAK inhibitor was complicated by development of red blood cells (RBC) transfusion requirement (2 units per month for 2 month); or grade 3 thrombocytopenia, anemia, hematoma/hemorrhage; or grade 2 non-hematologic toxicity while on JAK inhibitors
- Participants ≥18 years of age.
- Eastern Cooperative Oncology Group (ECOG) less than or equal to (≤) 2.
- Platelet count ≥75*10^9 per liter (/L).
- Absolute neutrophil count (ANC) ≥1.5*10^9/L.
- Serum direct bilirubin ≤1.5*upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5*ULN.
- Calculated creatinine clearance (CrCl) >15 milliliter (mL)/minute (min) based on the Cockcroft and Gault formula.
- Participants with active hepatitis B virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 International Units (IU)/mL.
- Participants with untreated hepatitis C virus (HCV) are eligible if there is a documentation of negative viral load per institutional standard.
- Participants with history of human immunodeficiency virus (HIV) are eligible if they have cluster of differentiation 4 (CD4)+ T-cell counts ≥350 cells/microliter (mcL), negative viral load per institutional standard, and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year.
- Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception throughout the study and for at least 90 days after the last dose of selinexor, or for the duration as stated on the label (SmPC/USPI) for those on the comparator drug (physician's choice arm). Childbearing potential excludes: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy.
- Male participants who are sexually active must use highly effective methods of contraception throughout the study and for at least 90 days after the last dose of selinexor, or for the duration as stated on the label (SmPC/USPI) for those on the comparator drug (physician's choice arm). Male participants must agree not to donate sperm during the study treatment period.
- Participants must sign written informed consent in accordance with federal, local and institutional guidelines.
Who cannot join
- >5% blasts in peripheral blood or >10% blasts in bone marrow (i.e., accelerated phase).
- Previous treatment with selinexor or other exportin 1 (XPO1) inhibitors.
- Use of any standard or experimental anti-MF therapy <21 days prior to Cycle 1 Day 1 (hydroxyurea or growth factors are allowed).
- Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor (Example: vomiting, or diarrhea that is Common Terminology Criteria for Adverse Events (CTCAE) grade >1).
- Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to selinexor dosing or strong CYP3A inducers ≤14 days prior to selinexor dosing.
- Major surgery <28 days prior to cycle 1 day 1 (C1D1).
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- Uncontrolled (ie, clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participants safety, prevent the participant from giving informed consent, or being compliant with the study procedures.
- Female participants who are pregnant or lactating.
- Participants with contraindications to use of selinexor or all the drugs intended to be used in the comparative treatment arm.
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
China7 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
The First Hospital of Jilin University
Changchun, Jilin, 130021
Sir Run Run Shaw Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Suzhou University -The First Affiliated Hospital
Suzhou, Jiangsu, 215007
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Italy5 sites
Università degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - Dipartimento di medicina sperimentale e clinica
Florence, 50134
Azienda Unita Sanitaria Locale Latina - Ospedale Santa Maria Goretti
Latina, 4100
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Meldola, Forlì-Cesena, 47014
University of Perugia Department of Medicine Hematology Section
Perugia, 6132
Asst Settelaghi, Ospedale Di Circolo E Fondazione Macchi
Varese, 21100
United States4 sites
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012
Illinois Cancer Specialist
Niles, Illinois, 60714
The Oncology Institute of Hope and Innovation
Pasadena, California, 91105
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
France2 sites
Centre Hospitalier Universitaire d'Angers (CHU Angers)
Angers, 49933
Institut de Cancéro-Hématologie
Brest, Brittany Region, 29609
About this study
Official title: A Phase 2, Randomized, Open-Label, Multicenter Study to Evaluate Safety and Efficacy of Single Agent Selinexor Versus Treatment of Physician's Choice in Patients With Previously Treated Myelofibrosis
This is a Phase 2, multicenter, two-arm, open-label study to evaluate the safety and efficacy of selinexor versus treatment per physician's choice (PC) in participants with myelofibrosis (MF) who had at least 6 months of treatment with a Janus kinase (JAK)1/2 inhibitor. Study participants will be randomized in a 1:1 ratio to either receive selinexor or physicians' choice of treatment.
- Conditions
- Myelofibrosis
- Being tested
- Selinexor, Physician's Choice Treatment
- Keywords
- Myelofibrosis, Selinexor, Total Symptom Score, Spleen Volume Reduction, Anemia response, TSS50, SVR35, SVR25, KPT-330, JAK1, JAK2, XPOVIO, SINE, XPORT-MF-035, Karyopharm
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Unit Dose Strength: 20 mg; Dose Formulation: Tablet; Dosage Level: 60 or 80 mg, QW; Route of Administration: Oral
Physician's Choice TreatmentOther
Physician's choice treatment may include ruxolitinib retreatment, fedratinib, chemotherapy (e.g., hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulatory agent, androgen, interferon (all as per clinical practice) and may include supportive care only with no MF treatment; no investigational therapies are allowed.
| Study group | Role | What they receive |
|---|---|---|
| Arm S: Selinexor | Experimental | Participants with MF who had previously received at least 6 months of treatment with JAK 1/2 inhibitor will receive a dose of selinexor 80 mg for first 2 cycles followed by selinexor 60 mg once weekly (QW) in subsequent cycles orally on Days 1, 8, 15, and 22 of each 28-day cycle to participants on Arm S. Receives: Drug: Selinexor |
| Arm PC: Physician's Choice Treatment | Active comparator | Participants with MF who had previously received at least 6 months of treatment with JAK 1/2 inhibitor will receive Physician's choice treatment which will be administered as per clinical practice. Receives: Other: Physician's Choice Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Spleen Volume Reduction of Greater Than or Equal to (≥) 35 Percent (%) (SVR35)
Measured: From Baseline up to Week 24
Secondary outcomes (11)
Percentage of Participants with Total Symptom Score Reduction of ≥50% (TSS50) Measured by Myelofibrosis Symptom Assessment Form (MFSAF) V4.0, Based on Local Assessment
Measured: From Baseline up to Week 24
Percentage of Participants with Spleen Volume Reduction of ≥25% (SVR25)
Measured: From Baseline up to Week 24
Overall Survival (OS)
Measured: From Baseline up to 12 months after end of treatment (approximately 48 months)]
Percentage of Participants with Anemia Response Assessed by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Measured: From Baseline up to 28 days after last dose (approximately 48 months)
Duration of Spleen Volume Reduction of ≥35% (SVR35)
Measured: From Baseline up to Week 24
Duration of Spleen Volume Reduction of ≥25% (SVR25)
Measured: From Baseline up to Week 24
Duration of Total Symptom Score is ≥50% (TSS50) Based on Local Assessment
Measured: From Baseline up to Week 24
Overall Response Rate (ORR) Assessed by IWG-MRT
Measured: From Baseline up to 28 days after last dose (approximately 48 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity Grade ≥3, Serious Adverse event (SAEs), and AEs Leading to Treatment Discontinuation
Measured: From first dose of study treatment up to 30 days after end of treatment (approximately 48 months)
Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Curve (AUC) of Selinexor
Measured: Cycle 2 Day 1: 1, 2, 4, and 6 hours post-dose; Cycle 2 Day 2: at 24 hours post-dose (each cycle is 28 days)
PK Parameter: Maximum Plasma Concentration (Cmax) of Selinexor
Measured: Cycle 2 Day 1: 1, 2, 4, and 6 hours post-dose; Cycle 2 Day 2: at 24 hours post-dose (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start17 Mar 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karyopharm Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562870
- Sponsor's protocol ID
- XPORT-MF-035
- Other IDs
- 2020-003809-60, 2024-513605-31-00
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2020
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grosicki S, Yimer H, Ayala R, Chen S, Liu H, Boyer F, Guglielmelli P, Brociner M, Sportoletti P, Mikala G, Tsirigotis P, Zhang J, Mark T, Chai Y, Ellero A, Lucchesi A. Single-Agent Selinexor Versus Physician's Choice in Previously Treated Myelofibrosis: Results From the Phase 2 XPORT-035 Study. EJHaem. 2026 Jun 1;7(3):e70301. doi: 10.1002/jha2.70301. eCollection 2026 Jun.
PubMed 42253638
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Multicenter Study to Evaluate Safety and Efficacy of Single Agent Selinexor Versus Treatment of Physician's Choice in Patients With Previously Treated Myelofibrosis
- ClinicalTrials.gov ID
- NCT04562870
- Acronym / sponsor ID
- XPORT-MF-035
- Conditions
- Myelofibrosis
- Keywords
- Myelofibrosis, Selinexor, Total Symptom Score, Spleen Volume Reduction, Anemia response, TSS50, SVR35, SVR25
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Karyopharm Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter, two-arm, open-label study to evaluate the safety and efficacy of selinexor versus treatment per physician's choice (PC) in participants with myelofibrosis (MF) who had at least 6 months of treatment with a Janus kinase (JAK)1/2 inhibitor. Study participants will be randomized in a 1:1 ratio to either receive selinexor or physicians' choice of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm S: Selinexor | Experimental | Drug: SelinexorParticipants with MF who had previously received at least 6 months of treatment with JAK 1/2 inhibitor will receive a dose of selinexor 80 mg for first 2 cycles followed by selinexor 60 mg once weekly (QW) in subsequent cycles orally on Days 1, 8, 15, and 22 of each 28-day cycle to participants on Arm S. |
| Arm PC: Physician's Choice Treatment | Active comparator | Other: Physician's Choice TreatmentParticipants with MF who had previously received at least 6 months of treatment with JAK 1/2 inhibitor will receive Physician's choice treatment which will be administered as per clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- A diagnosis of primary MF or post-essential thrombocythemia (ET) or post-polycythemia (PV) MF according to the 2016 World Health Organization (WHO) classification of myeloproliferative neoplasms (MPN), by the most recent local pathology report.
- Previous treatment with JAK inhibitors for at least 6 months.
- Measurable splenomegaly during the screening period as demonstrated by spleen volume of ≥450 centimeter cube (cm^3) by magnetic resonance imaging (MRI) or computerized tomography (CT) scan.
- Relapsed, Refractory or Intolerant to JAK inhibitors as defined as meeting one of the criteria below:
- Participants ≥18 years of age.
Key exclusion criteria (10 listed)
- >5% blasts in peripheral blood or >10% blasts in bone marrow (i.e., accelerated phase).
- Previous treatment with selinexor or other exportin 1 (XPO1) inhibitors.
- Use of any standard or experimental anti-MF therapy <21 days prior to Cycle 1 Day 1 (hydroxyurea or growth factors are allowed).
- Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor (Example: vomiting, or diarrhea that is Common Terminology Criteria for Adverse Events (CTCAE) grade >1).
- Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to selinexor dosing or strong CYP3A inducers ≤14 days prior to selinexor dosing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelinexorUnit Dose Strength: 20 mg; Dose Formulation: Tablet; Dosage Level: 60 or 80 mg, QW; Route of Administration: Oral | Drug | Arm S: Selinexor |
| Physician's Choice TreatmentPhysician's choice treatment may include ruxolitinib retreatment, fedratinib, chemotherapy (e.g., hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulatory agent, androgen, interferon (all as per clinical practice) and may include supportive care only with no MF treatment; no investigational therapies are allowed. | Other | Arm PC: Physician's Choice Treatment |
Primary outcome
Percentage of Participants with Spleen Volume Reduction of Greater Than or Equal to (≥) 35 Percent (%) (SVR35)
Time frame: From Baseline up to Week 24
11 secondary outcomes
Percentage of Participants with Total Symptom Score Reduction of ≥50% (TSS50) Measured by Myelofibrosis Symptom Assessment Form (MFSAF) V4.0, Based on Local Assessment
Time frame: From Baseline up to Week 24
Percentage of Participants with Spleen Volume Reduction of ≥25% (SVR25)
Time frame: From Baseline up to Week 24
Overall Survival (OS)
Time frame: From Baseline up to 12 months after end of treatment (approximately 48 months)]
Percentage of Participants with Anemia Response Assessed by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Time frame: From Baseline up to 28 days after last dose (approximately 48 months)
Duration of Spleen Volume Reduction of ≥35% (SVR35)
Time frame: From Baseline up to Week 24
Duration of Spleen Volume Reduction of ≥25% (SVR25)
Time frame: From Baseline up to Week 24
Duration of Total Symptom Score is ≥50% (TSS50) Based on Local Assessment
Time frame: From Baseline up to Week 24
Overall Response Rate (ORR) Assessed by IWG-MRT
Time frame: From Baseline up to 28 days after last dose (approximately 48 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity Grade ≥3, Serious Adverse event (SAEs), and AEs Leading to Treatment Discontinuation
Time frame: From first dose of study treatment up to 30 days after end of treatment (approximately 48 months)
Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Curve (AUC) of Selinexor
Time frame: Cycle 2 Day 1: 1, 2, 4, and 6 hours post-dose; Cycle 2 Day 2: at 24 hours post-dose (each cycle is 28 days)
PK Parameter: Maximum Plasma Concentration (Cmax) of Selinexor
Time frame: Cycle 2 Day 1: 1, 2, 4, and 6 hours post-dose; Cycle 2 Day 2: at 24 hours post-dose (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 42253638Grosicki S, Yimer H, Ayala R, Chen S, Liu H, Boyer F, Guglielmelli P, Brociner M, Sportoletti P, Mikala G, Tsirigotis P, Zhang J, Mark T, Chai Y, Ellero A, Lucchesi A. Single-Agent Selinexor Versus Physician's Choice in Previously Treated Myelofibrosis: Results From the Phase 2 XPORT-035 Study. EJHaem. 2026 Jun 1;7(3):e70301. doi: 10.1002/jha2.70301. eCollection 2026 Jun.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selinexor and Physician's Choice Treatment in people with Myelofibrosis, run by Karyopharm Therapeutics Inc at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China, Italy, United States, France, Greece and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Spleen Volume Reduction of Greater Than or Equal to (≥) 35 Percent (%) (SVR35) (time frame: From Baseline up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.