A Phase 2 interventional study of Luspatercept and Pacritinib in Myelofibrosis, sponsored by Case Comprehensive Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Case Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
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Among 18 studies testing pacritinib in Primary Myelofibrosis — 6 open to participants now, 8 under way, 1 of them phase 3. pacritinib · Primary Myelofibrosis.
Among the 18 studies testing pacritinib in Primary Myelofibrosis, this one is the 8th largest by planned enrollment, is one of 3 that started in 2026, is one of 8 in phase 2, and was the 18th registered.
626 studies on the registry are indexed under Primary Myelofibrosis; 125 are open to participants now.
Browse Primary Myelofibrosis studies →6 of the 18 studies testing pacritinib in Primary Myelofibrosis are open now, in 2 countries. Recruiting first, the newest first:
John Mascarenhas · Sites in United States
Ages 18+
Grupo Español de Enfermedades Mieloproliferativas Crónicas PH Negativas · Sites in Spain
Ages 18+
University of Kansas Medical Center · Sites in United States
Ages 18+ · Healthy volunteers
Fox Chase Cancer Center · Sites in United States
Ages 18+
University of Washington · Sites in United States
Ages 18+
By country, each count listing its studies:
pacritinib: first FDA approval 2022 (VONJO). What it is approved for, and how studies give it, is on its page →
Of the 102 Primary Myelofibrosis studies recruiting now, 84 (82%) set no upper age limit and 13 (13%) stop at 75 or younger; 10 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 10 · Phase 3 3
First in 2008; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is above the median of 43 across 490 interventional studies indexed under Primary Myelofibrosis.
Median enrollment 35 across the 18 interventional studies. Of the 8 that completed or were terminated, 4 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 18 have an industry lead sponsor. The 10 most frequent:
Case Comprehensive Cancer Center is the lead sponsor of 495 studies on the registry; 60 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
12 studies in Primary Myelofibrosis by Case Comprehensive Cancer Center: 1 open now, 1 under way, none of them phase 3. Of 10 finished, 0 (0%) have results posted.
Among the 12 studies in Primary Myelofibrosis by Case Comprehensive Cancer Center, this one is the 4th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2026, is one of 4 in phase 2, and was the 12th registered.
Case Comprehensive Cancer Center’s Primary Myelofibrosis studies by the year they started, since 2000.
2 of the studies testing pacritinib in Primary Myelofibrosis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06414681University of Kansas Medical CenterCombination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined | 2026-12 |
| NCT04282187University of WashingtonDecitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms | 2027-11-11 |
Add all 2 to your calendar (.ics) → With an account.
Among the 18 studies testing pacritinib in Primary Myelofibrosis, from their registry updates:
Among Case Comprehensive Cancer Center’s 12 in Primary Myelofibrosis:
This tab as a report to print or save as PDF → With an account.
This study is for participants who have been diagnosed with myelofibrosis with cytopenia. Luspatercept and Pacritinib are experimental drug combination that works by blocking certain enzymes to calm an overactive inmmune system to reduce inflammation which would allow red blood cells to mature. The purpose of this study is to find out if the combination of Luspatercept and Pacritinib can help improve hemobglobin or transfusion dependents in participants with myelofibrosis with cytopenias.
Myelofibrosis is a type of bone cancer that mainly affects the elderly. Myeolofibrosis can either develop on its own, or it can be caused by other blood cell conditions. Myeolofibrosis causes scarring in the bone marrow that makes it hard to produce healthy read blood cells. This increases the risk of participants developing anemia at diagnosis, but eventually most affected participants develop anemia. Anemia is a complication of using Janus Kinase inhibitors, which are the main agents used to treat MF. Almost half of the participants who develop anemia require red blood cell transfusion support. Anemia causes poor quality of life, especially in participants who are transfusion dependent.
The goal of this study is to find out if using a combination of Luspatercept and Pacritinib can help decrease anemia in particpants with MF and improve the quality of life by requiring less blood transfusions. This combination works by blocking certain enzymes to calm an overactive immune system and reduce inflammation. This allows red blood cells to mature. Luspatercept will be given through subcutaneous injections on the first day of the study cycle, and pacritinib will be given in an oral pill that will be taken 2 times per day. About 50 participants are planned to be enrolled in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with myelofibrosis as defined by WHO criteria - either primary or secondary myelofibrosis with:
Anemia:
A female of (FCBP) for this study is defined as a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (eg, has had menses at any time in the preceding 24 consecutive months). Females of childbearing potential (FCBP) participating in the study must:
Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective # 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 12 weeks (approximately 5 times the mean terminal half-life of IP based on multiple-dose PK data) after discontinuation of study therapy.
Practice true abstinence* (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential who is or is not using contraception** while participating in the study, during dose interruptions and for at least 12 weeks (approximately 5 times the mean terminal half-life of IP based on multiple-dose PK data) following IP discontinuation, even if he has undergone a successful vasectomy.
True abstinence is acceptable when it is in line with the preferred and usual lifestyle of the participant. [Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.]
Agreement to use highly effective methods of contraception that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly throughout the course of the study. Such methods include: Placement of an intrauterine device (IUD); Bilateral tubal occlusion; Vasectomized partner; Sexual Abstinence.
Exclusion Criteria:
4.2.5. Participant with anemia from cause other than MF or JAK2 inhibitor therapy (eg, iron deficiency, vitamin B12 and/or folate deficiencies, or hemolytic anemia, infection, or any type of known bleeding or sequestration).
Participant use of hydroxyurea, immunomodulatory compounds such as pomalidomide, thalidomide, ESAs, androgenic steroids, strong inhibitors and inducers, or other drugs with potential effects on hematopoiesis ≤ 2 weeks up to the end of the screening period.
Participant with any of the following laboratory abnormalities at screening:
Participant with prior history of , other than disease under study, unless the participant has been free of the disease for ≥ 3 years. However, participants with the following history/concurrent conditions are allowed (if they have already undergone treatment with curative intent):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Luspatercept will be given through subcutaneous injection on Day 1of each cycle at a starting dose of 1.33 milligrams/kilogram and can go up to a maximum dose of 1.75 milligrams/kilogram. Pacritinib will be given twice daily orally at a dose of 200 milligrams. Each cycle lasts 21 days.
Drug: Luspatercept · Drug: Pacritinib
Luspatercept will be given through subjecutaneous injection on Day 1of each cycle at a dose of 1.33-1.75mg/kg.
Pacritinib will be given twice daily orally at a dose of 200mg.
Rate of major response for anemia
The rate of major response for anemia is defined as per 2024 IWG-ELN response criteria for transfusion dependent and non-transfusion dependent partipants with myelofibrosis.
Time frame: week 24
Rate of minor response for anemia
Minor response for anemia is defined as per 2024 IWG-ELN response criteria for transfusion dependent and non-transfusion dependent partipants with myelofibrosis.
Time frame: week 24
Safety of luspatrecept and pacritinib combination
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) according to the CTCAE.
Time frame: up to 24 weeks
Tolerability of luspatrecept and pacritinib combination
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) according to the CTCAE.
Time frame: up to 24 weeks
Proportion of participants achieving an anemia response
Anemia response during the entire treatment period, defined as a greater than or equal to 1.5 g/dL increase in hemoglobin during the entire treatment period
Time frame: up to 24 weeks
Time to anemia response
Defined as time from first dose to first onset of anemia response during the 24 week primary treatment period
Time frame: up to 24 weeks
Duration of anemia response
Defined as the amount of time from the onset of longest anemia response to loss of that response per IWG ELN 2024 criteria during the primary treatment period
Time frame: up to 24 weeks
Proportion of participants achieving a greater than 50% reduction in total symptom score
As defined by the myeolofibrosis Symptom Assessment form v.4.0 (MF-SAF)
Time frame: up to 24 weeks
Change in spleen size
Evaluate change in spleen size, assessed by spleen length on ultrasound and palpable spleen length below the left costal margin
Time frame: up to 24 weeks
Plan to share: Yes — All participant data will be shared via peer-reviewed publication as a combined summary. Any individual outcomes published per subject will be deidentified utilizing the subject ID (eg. Dose level, demographics, adverse events etc.)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data included in the peer reviewed publication will be publicly available. No raw data will be shared.
Access criteria: A peer-reviewed publication will be made available according to the publishing journal's specifications. CCF personnel will not share study data apart from that which has been published publicly
Data sharing details ↗ · pubmed.ncbi.nlm.nih.gov
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jan 2029, 25 months later.
Of 68 non-industry phase 2 interventional studies under Primary Myelofibrosis, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 119. This study's planned 25 months is below that.
Counting every sponsor, half of 98 studies reached it within 66 months; a quarter within 32 and three quarters within 111.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Luspatercept · Pacritinib
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