Recruiting
Phase 2

Pacritinib & Selinexor

Sponsor:

John Mascarenhas

Code:

NCT07447817

Conditions

Myelofibrosis

Post-polycythemia Vera Myelofibrosis

Post-essential Thrombocythemia Myelofibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pacritinib

Selinexor

Study Details

Brief summary:

This is a phase II, multicenter, open-label trial evaluating the safety and efficacy of pacritinib and selinexor in JAK inhibitor naïve patients with anemia and thrombocytopenia.

Conditions

Myelofibrosis

Post-polycythemia Vera Myelofibrosis

Post-essential Thrombocythemia Myelofibrosis

Study ID

NCT07447817

Start date

Oct 23, 2026

Status verified date

Oct, 2026

Completion date

May 24, 2030

Anticipated

Primary completion date

May 24, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pacritinib/Selinexor

Study participants will receive pacritinib monotherapy (200mg BID orally) for the first cycle (28 days). If they qualify to add on selinexor at any point from Cycle 2 Day 1 to Cycle 4 Day 1, participants will have selinexor (60mg QW orally) added onto their pacritinib regimen.

Interventions

Pacritinib

Pacritinib 200mg twice a day (BID) by mouth (PO)

Selinexor

Selinexor 60mg once weekly (QW) by mouth (PO)

Primary outcome measure

  • Change in spleen volume [ Time Frame: Baseline and 24 weeks ]

Central Contacts and Locations

Central contacts

Gillian Sanchez

(917) 581-1774gillian.sanchez@mssm.edu

Shakira Forde

212-824-8334shakira.forde@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

John Mascarenhas

More Information

Sponsor

John Mascarenhas

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Keywords

  • Myelofibrosis
  • Anemia
  • Thrombocytopenia
  • Pacritinib
  • Selinexor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by John Mascarenhas on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.