NL-OMON40900已完成3 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 - PAC326, PERSIST-2
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Intermediate-1, intermediate -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 lower costal margin (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
- •7. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- •8. Peripheral blast count <10%
- •9. Absolute neutrophil count (ANC) >500/*L
- •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 × 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 outcome instrument
- •19. Able to understand and willing to sign the Informed Consent Form
排除标准
- •1. Any gastrointestinal (GI) or metabolic condition that could interfere with absorption of oral
- •2. Life expectancy less than 6 months
- •3. Prior treatment with more than 2 JAK2 inhibitors or with pacritinib
- •4. There is no maximum of cumulative prior JAK2 inhibitor treatment (approved or investigational)
- •5. Completed allogeneic stem cell transplant (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 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 Criteria 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 >450ms, or other factors that increase the risk for QT interval
- •prolongation (eg, heart failure, hypokalemia [defined as serum potassium <3.0mEq/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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