New drug combo aims to shrink spleen in Hard-to-Treat myelofibrosis
NCT ID NCT07447817
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests two oral drugs, selinexor and pacritinib, in 26 adults with myelofibrosis who have anemia and low platelets and have not taken JAK inhibitors before. The main goal is to see if the combination can shrink the spleen by at least 35%. The study also tracks symptom improvement and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- selinexor and pacritinib (two oral drugs)
- What this could lead to
- If it works, this could offer a new treatment option for myelofibrosis patients who cannot take standard JAK inhibitors due to low blood counts.
- What could go wrong
- This is a small, early-phase trial with only 26 participants. The combination may cause side effects or fail to shrink the spleen enough. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults ≥ 18 years of age capable of providing informed consent * Pathologically confirmed diagnosis of PMF, post-ET MF, or post-PV MF as per the World Health Organization (WHO) diagnostic criteria - Intermediate-1, Intermediate-2, or High-Risk disease by the Dynamic International Prognostic Scoring System (DIPSS) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Baseline splenomegaly ≥ 5cm palpable below the left costal margin and in the midclavicular line OR ≥ 450cc by imaging (i.e. ultrasound, CT, MRI) * Baseline anemia, defined by hemoglobin \< 10 g/dL within 28 days prior to Cycle 1 Day 1 * Baseline thrombocytopenia, defined by platelet count 50-150 x 109/L without platelet transfusions within 28 days prior to Cycle 1 Day 1 * Adequate organ function as demonstrated by the following within 28 days prior to Cycle 1 Day 1: * ALT (SGPT) and/or AST (SGOT) ≤ 3x the upper limit of normal (ULN), or ≤ 4 x ULN if, upon judgment of the treating physician, it is believed to be due to MF-related extramedullary hematopoiesis (EMH); * Direct bilirubin ≤ 1.5 x ULN; or ≤ 2x ULN if, upon judgment of the treating physician, it is believed to be due to MF-related extramedullary hematopoiesis (EMH) or documented Gilbert's syndrome; * Creatinine clearance ≥ 30 mL/min; * Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (Exceptions to coagulation parameters may be considered for patients who are taking concomitant anticoagulation medications or have a documented anti-phospholipid antibody, after discussion with Study Chair approval) * Bone marrow and/or peripheral blood blast count \< 5%; and * Absolute neutrophil count (ANC) ≥ 1500 mm3 without need for growth factors within 7 days prior to Cycle 1 Day 1. * Recovery to ≤ Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia * Life expectancy of at least six months * Patients with active hepatitis B virus are eligible if antiviral therapy for hepatitis B has been given for \>8 weeks and the viral load is \<100 IU/mL. * Patients with history of hepatitis C virus (HCV) are eligible if they have received adequate curative anti-HCV treatment and HCV viral load is below the limit of quantification. * Patients with history of human immunodeficiency virus are eligible if they have cluster of differentiation (CD)4+ T-cell counts ≥350 cells/μL, negative viral load, and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year and should be on established antiretroviral therapy for at least 4 weeks. * Women of childbearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after the last dose of study therapy * Able to adhere to the study visit schedule and all protocol requirements Exclusion Criteria: * Prior treatment with Janus kinase (JAK) inhibitors * Prior treatment with selinexor or other Exportin 1 (XPO1) inhibitors * Treatment with any MF-directed therapy (including investigational therapies and excluding hydroxyurea) within 2 weeks or 5.5 half-lives, whichever is shorter, of Cycle 1 Day 1 * Completed hematopoietic cell transplant (HCT) * Prior splenectomy, splenic irradiation, or splenic artery embolization within 6 months of Cycle 1 Day 1 * Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of pacritinib or selinexor, including any unresolved nausea, vomiting, or diarrhea \> National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0 Grade 1 * Uncontrolled or currently progressing ocular toxicities * Moderate or severe cardiovascular disease meeting one or both of the below criteria: * Presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension * Documented major electrocardiogram (ECG) abnormalities (not responding to medical treatments) * Grade 2 or greater bleeding event within the past 6 months * QT corrected by the Fridericia method (QTcF) prolongation \> 480 ms or other factors that increase the risk for QT interval prolongation (eg, hypokalemia \[defined as serum potassium \< 3.0 mEq/L that is persistent and refractory to correction\], or history of long QT interval syndrome) * Recipient of organ transplant * History of major surgery or any planned surgical procedures within 28 days prior to Cycle 1 Day 1 * Other malignancy within the last three years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated non-metastatic prostate cancer with normal prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial/non-invasive transitional cell bladder carcinoma. * Presence of active serious infection * Use of any prohibited medications (5.8) within two weeks or five half-lives, whichever is longer, prior to Cycle 1 Day 1 * Women who are pregnant or lactating * Any serious, unstable medical or psychiatric condition that would prevent (as judged by the Investigator) the subject from signing the informed consent form (ICF) or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study * Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific subject
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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The University of Kansas Cancer Center-Westwood
Westwood, Kansas, 66205, United States
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Wake Forest Baptist Health Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Half-Matched stem cells tested as cure for myelofibrosis
- Can blood tests predict transplant complications?
- Can a new daily pill shrink the spleen and ease myelofibrosis symptoms?
- Can a new pill tame myelofibrosis?
- MRI as a window into bone marrow disease: a new biomarker test?
- Can a menin inhibitor tame myelofibrosis when standard drugs fall short?