Myeloproliferative Neoplasms Clinical Trial
Pacritinib Versus Best Available Therapy to Treat Myelofibrosis
Summary
Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.
Full Description
Multicenter, randomized, controlled, phase 3 trial comparing the safety and efficacy of pacritinib with that of BAT in patients with primary or secondary myelofibrosis. Approximately 322 eligible patients will be randomized in a 2:1 allocation to pacritinib (400mg QD) or BAT (includes any physician-selected treatment for myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases)). Spleen volume will be measured by MRI or CT at baseline and every 12 weeks thereafter. An independent radiology facility (IRF), blind to treatment assignments, will measure spleen volumes. Patients will also be followed for safety, Leukemia Free Survival (LFS), Overall Survival (OS), frequency of red blood cell (RBC) and platelet transfusions, and other exploratory endpoints. An Independent Data Monitoring Committee (IDMC) will evaluate the safety of pacritinib.
Eligibility Criteria
Inclusion Criteria:
Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)
Palpable splenomegaly ≥ 5 cm on physical examination
Total Symptom Score >13 on the MPN-SAF TSS 2.0, not including the inactivity question
Patients who are platelet or red blood cell transfusion-dependent are eligible
Adequate white blood cell counts (with low blast counts), liver function, and renal function
No spleen radiation therapy for 6-12 months
Last therapy for myelofibrosis was 2-4 weeks ago, including any erythropoietic or thrombopoietic agent
Not pregnant, not lactating, and agree to use effective birth control
Exclusion Criteria:
Prior treatment with a JAK2 inhibitor
History of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant
Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipation
Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction
Other malignancy within last 3 years other than certain limited skin, cervical, prostate, breast, or bladder cancers
Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study
Life expectancy < 6 months
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 4 Locations for this study
Scottsdale Arizona, 85259, United States
Omaha Nebraska, 68198, United States
Morristown New Jersey, 07962, United States
Greenville South Carolina, 29601, United States
Box Hill , , Australia
Coffs Harbour , , Australia
Geelong , , Australia
Gosford , , Australia
Hobart , , Australia
Milton , , Australia
Antwerp , , Belgium
Antwerp , , Belgium
Brugge , , Belgium
Bruxelles , , Belgium
La Louviere , , Belgium
Brno , , Czechia
Olomouc , , Czechia
Plzen , , Czechia
Prague , , Czechia
Amiens , , France
Caen , , France
Grenoble , , France
Lens , , France
Lille , , France
Nimes Cedex , , France
Paris , , France
Paris , , France
Pessac , , France
Pierre Benite , , France
Strasbourg , , France
Toulouse , , France
Berlin , , Germany
Berlin , , Germany
Dresden , , Germany
Essen , , Germany
Freiburg , , Germany
Koln , , Germany
Mainz , , Germany
Munchen , , Germany
Munster , , Germany
Budapest , , Hungary
Debrecen , , Hungary
Gyula , , Hungary
Kaposvar , , Hungary
Kecskemet , , Hungary
Szeged , , Hungary
Szolnok , , Hungary
Szombathely , , Hungary
Bologna , , Italy
Firenze , , Italy
Milano , , Italy
Monza , , Italy
Padova , , Italy
Reggio Emilia , , Italy
Rimini , , Italy
Amsterdam , , Netherlands
Maastricht , , Netherlands
Rotterdam , , Netherlands
Utrecht , , Netherlands
Christchurch , , New Zealand
Dunedin , , New Zealand
Hamilton , , New Zealand
Takapuna , , New Zealand
Izhevsk , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Petrozavodsk , , Russian Federation
Saint Petersburg , , Russian Federation
Samara , , Russian Federation
Sochi , , Russian Federation
St. Petersburg , , Russian Federation
St. Petersburg , , Russian Federation
Volgograd , , Russian Federation
Birmingham , , United Kingdom
Bournemouth , , United Kingdom
Cambridge , , United Kingdom
Cardiff , , United Kingdom
London , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
Oxford , , United Kingdom
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.