Not Yet RecruitingPhase 2

Selinexor Monotherapy for Cytoreduction in BCR::ABL1-Negative Myeloproliferative Neoplasms

15 participantsStarted 2026-07-01

Plain-language summary

Myeloproliferative neoplasms are chronic blood cancers in which the bone marrow produces too many blood cells. Patients with Philadelphia chromosome-negative myeloproliferative neoplasms, including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may need treatment to reduce high blood cell counts, relieve disease-related symptoms, and lower the risk of complications. However, currently available cytoreductive treatments may be ineffective, poorly tolerated, or inconvenient for some patients. Selinexor is an oral selective inhibitor of nuclear export that has shown antitumor activity in several hematologic malignancies. This study will evaluate the effectiveness and safety of selinexor used alone as cytoreductive treatment in patients with Philadelphia chromosome-negative myeloproliferative neoplasms who have an indication for cytoreductive therapy. This is a prospective, single-arm, open-label phase II study conducted at a single center. Eligible participants will receive oral selinexor, with dose adjustments based on tolerability and blood cell counts. Participants will be followed for treatment response, symptom improvement, and side effects for up to 6 months. The results of this study may help determine whether selinexor could provide a potential treatment option for patients with Philadelphia chromosome-negative myeloproliferative neoplasms who have limited cytoreductive therapy choices.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 to 80 years at the time of informed consent. * Diagnosis of Philadelphia chromosome-negative myeloproliferative neoplasm, including polycythemia vera, essential thrombocythemia, or primary myelofibrosis, according to World Health Organization criteria. * Presence of an indication for cytoreductive therapy, including at least one of the following: * Extreme thrombocytosis, defined as platelet count \>1500 x 10\^9/L. * Progressive leukocytosis, defined as white blood cell count \>25 x 10\^9/L. * Symptomatic splenomegaly documented by imaging. * Severe disease-related symptoms, such as significant weight loss within the past 6 months. * Unwillingness or inability to tolerate standard cytoreductive therapies, such as hydroxyurea or interferon. * Eastern Cooperative Oncology Group performance status of 0 to 2. * Adequate organ function, including renal, hepatic, cardiac, and coagulation function, as determined by laboratory tests and clinical evaluation in the opinion of the investigator. * Adequate baseline hematologic function without recent transfusion or growth factor support. * Ability to comply with study procedures, visits, and assessments. * Ability to understand and willingness to sign a written informed consent form. * For women of childbearing potential, a negative pregnancy test before study entry. * For participants of reproductive potential, agreement to use effective contraception during the study and for at least 120 days after the la…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Participants Achieving Disease-Relevant Peripheral Blood Count Control

Timeframe: Up to 6 months after initiation of study treatment

Trial details

NCT IDNCT07626021

SponsorZhongshan Hospital (Xiamen), Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

Zheng Wei

+86-13916563166 wei.zheng@zs-hospital.sh.cn

View on ClinicalTrials.gov More Myeloproliferative Neoplasms trials