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NOT YET RECRUITING
NCT07626021
PHASE2

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

Sponsor: Zhongshan Hospital (Xiamen), Fudan University

View on ClinicalTrials.gov

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.

Official title: An Open-Label, Single-Arm Phase II Study of Selinexor Monotherapy for Cytoreduction in Patients With BCR::ABL1-Negative Myeloproliferative Neoplasms

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-07-01

Completion Date

2026-08-31

Last Updated

2026-06-04

Healthy Volunteers

No

Interventions

DRUG

Selinexor

Selinexor will be administered orally at an initial dose of 40 mg once weekly. Treatment may be continued for up to 3 months, with a planned total follow-up period of 6 months. Dose escalation to 60 mg or 80 mg once weekly is permitted in participants without significant hematologic or non-hematologic toxicity, according to the investigator's judgment. Dose interruption and dose reduction are allowed based on safety and tolerability. In the event of grade 3 or higher hematologic toxicity or clinically significant non-hematologic toxicity, selinexor will be temporarily withheld and resumed at a reduced dose after recovery. Treatment will be permanently discontinued if unacceptable toxicity persists despite dose modification.