Oral Pacritinib Versus Best Available Therapy to Treat Myelofibrosis With Thrombocytopenia (PAC326)
- Conditions
- Primary MyelofibrosisCancer - Myeloma
- Registration Number
- ACTRN12614000740695
- Lead Sponsor
- Cell Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)
Thrombocytopenia (platelet count greater than 100,000/microlitre) at any time after signing informed consent
Palpable splenomegaly greater than 5 cm on physical examination
Total Symptom Score less than 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
At least 6 months from prior splenic irradiation
At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent
Not pregnant, not lactating, and agree to use effective birth control
Able and willing to undergo frequent MRI or CT assessments and complete symptom assessments using a patient-reported outcome instrument
Prior treatment with more than 2 JAK2 inhibitors or with pacritinib
More than 6 months of cumulative prior JAK2 inhibitor treatment
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
Active bleeding that requires hospitalization during the screening period
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy [Baseline to Week 24]]<br>To compare the efficacy of two dose-schedule arms of pacritinib (pooled once-daily and twice-daily dosing arms) with that of Best Available Therapy in patients with thrombocytopenia and primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis; the efficacy measure for this analysis is the proportion of patients achieving a greater than 35% reduction in spleen volume from baseline to week 24 by magnetic resonance imaging (MRI) or computed tomography (CT) and the proportion of patients achieving a greater than 50% reduction in total symptom score from baseline to Week 24 as measured by the Myeloproliferative Neoplasm Symptom Assessment Form 2.0.[Baseline to Week 24]
- Secondary Outcome Measures
Name Time Method