A study comparing current standard therapies with pacritinib taken by mouth for the treatment of myelofibrosis (either diagnosed alone or after polycytemia vera or essential thrombocytemia).
- Conditions
- Primary myelofibrosis, post-polycytemia vera myelofibrosis and post-essential thrombocytemia myelofibrosis.MedDRA version: 14.1Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2012-004239-21-IT
- Lead Sponsor
- CELL THERAPEUTICS INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
a) Intermediate-1, intermediate -2, or high-risk PMF, PPV-MF or PET-MF; b) Palpable splenomegaly = 5 cm below lower costal margin (LCM) in midclavicular line by physical examination; c) Score = 3 for at least two symptoms on the MPN-SAF-TSS or score = 4 for at least one symptom on MPN-SAF TSS other than fatigue; d) Age = 18 years old; e) Eastern Cooperative Oncology Group (ECOG) performance status 0-3; f) Peripheral blast count < 10%; g) Absolute neutrophil count > 500/µL; h) Patients who are platelet or red blood cell transfusion-dependent are eligible; i) Adequate liver and renal function, defined by liver transaminases (AST/SGOT and ALT/SGPT) = 3 × ULN AST/ALT = 5 × ULN if transaminase elevation is related to MF), direct bilirubin = 4 x ULN, and creatinine = 2.5 mg/dL; l) At least 6 months from prior splenic irradiation; m) At least 12 months from prior 32P therapy; n) At least 1 week since prior treatment (most recent dose) with a potent CYP3A4 inhibitor; o) At least 4 weeks since any experimental treatment for PMF, PPV-MF, or PET-MF; p) At least 2 weeks since any treatment for PMF, PPV-MF, or PET-MF.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
a) Any GI or metabolic condition that could interfere with absorption of oral medication; b) Life expectancy < 6 months; c) Prior treatment with a JAK2 inhibitor; d) Completed allogeneic stem cell transplant (ASCT) or eligible for and willing to complete ASCT; e) History of splenectomy or planning to undergo splenectomy; f) Uncontrolled intercurrent illness, including but not limited to ongoing active infection or psychiatric illness or social situation that the treating physician judges would limit compliance with study requirements; g) other malignancy within last 3 years other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated nonmetastatic prostate cancer with negative prostatespecific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma; h) Inflammatory or chronic functional bowel disorder such as Crohn disease, inflammatory bowel disease, chronic diarrhea, or constipation; i) Clinically symptomatic and uncontrolled cardiovascular disease; l) History of myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure within 6 months prior to study randomization; m) New York Heart Association Class II, III, or IV congestive heart failure (Appendix 9) ? Ongoing cardiac dysrhythmias of grade ? 2, QTc prolongation > 480 ms, or other factors that increase the risk for QT interval prolongation (eg, heart failure, hypokalemia defined as serum potassium < 3.0 mEq/L, family history of long QT interval syndrome); n) Erythropoietic agent within 28 days prior to randomization; o) thrombopoietic agent within 14 days prior to randomization
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method