EUCTR2013-004000-19-CZ进行中（未招募）1 期
A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis - PERSIST-2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Intermediate-1 or -2 or high-risk PMF, PPV-MF, or PET-MF
- •2. Thrombocytopenia (platelet count =100,000/µL) at any time after signing informed consent
- •3. Informed consent may be signed up to 35 days prior to randomization
- •4. Palpable splenomegaly =5 cm below the LCM in midclavicular line by physical examination
- •5. Total Symptom Score (TSS) =13 on the MPN-SAF-TSS 2.0, not including the inactivity question
- •6. Age =18 years old
- •7. ECOG performance status 0 to 3
- •8. Peripheral blast count <10%
- •9. Absolute neutrophil count (ANC) >500/µL
- •10. Patients who are platelet or RBC transfusion-dependent are eligible
- •11. 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
- •12. At least 6 months from prior splenic irradiation
- •13. At least 12 months from prior 32P therapy
- •14. At least 1 week since prior treatment (most recent dose) with a potent cytochrome P450 3A4 (CYP3A4) inhibitor
- •15. At least 2 weeks since receiving any treatment for PMF, PPV-MF, or PET-MF
- •16. If fertile, males and females must agree to use effective birth control methods during the study.
- •17. Willing to undergo and able to tolerate frequent MRI or CT assessments during the study
- •18. Able to understand and willing to complete symptom assessments using a patient-reported outcomes instrument
- •19. Able to understand and willing to sign the informed consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •1. Any gastrointestinal (GI) or metabolic condition that could interfere with absorption of oral medication
- •2. Life expectancy less than 6 months
- •3. Prior treatment with more than 2 JAK2 inhibitors or pacritinib
- •4. There is no maximum cumulative prior JAK2 inhibitor treatment (approved or investigational)
- •5. Completed allogeneic stem cell transplantation (ASCT) or are eligible for and willing to complete ASCT
- •6. History of splenectomy or planning to undergo splenectomy
- •7. Uncontrolled intercurrent illness, including but not limited to ongoing active infection, psychiatric illness, or social situation that, in the judgment of the treating physician, would limit compliance with study requirements
- •8. Active bleeding requiring hospitalization during the screening period
- •9. Other malignancy within the 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 prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma
- •10. Inflammatory or chronic functional bowel disorder, such as Crohn’s disease, inflammatory bowel disease, chronic diarrhea, or constipation
- •11. Clinically symptomatic and uncontrolled cardiovascular disease
- •12. History of any of the following within 6 months prior to randomization: myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure
- •13. New York Heart Association Class III or IV congestive heart failure
- •14. Patients with National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) grade 2 cardiac arrhythmias may be considered for inclusion with the approval of the medical monitor if the arrhythmias are stable, asymptomatic and unlikely to affect patient safety. Patients will be excluded if they have ongoing cardiac dysrhythmias of CTCAE grade =3, corrected QT interval (QTc) prolongation >450 ms, or other factors that increase the risk for QT prolongation (eg, heart failure, hypokalemia [defined as serum potassium < 3.0 mEq/L that is persistent and refractory to correction], or family history of long QT interval syndrome).
- •15. Erythropoietic agent within 28 days prior to randomization
- •16. Thrombopoietic agent within 14 days prior to randomization
- •17. Known seropositivity for human immunodeficiency virus (HIV)
- •18. Known active hepatitis A, B, or C virus infection
- •19. Women who are pregnant or lactating
研究者
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已完成
3 期
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