CTRI/2023/11/060327招募中3 期
A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts 50,000/µL) - NI
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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
入选标准
- •1. PMF (including pre-fibrotic MF), PPV-MF, or PET-MF (Tefferi and Vandiman 2008)
- •2. Average platelet count of <50,000/µL at Screening (Day -35 to Day -3) based on two measurements taken on different days; both measurements must be <50,000/µL
- •3. DIPSS Intermediate-1, Intermediate-2, or High risk (Passamonti et al 2010)
- •4. Palpable splenomegaly =5 cm below the lower costal margin (LCM) in the midclavicular line as assessed by physical examination
- •5. TSS of =10 on the MPN-SAF TSS 2.0 or a single symptom score of =5 or two symptoms of =3, including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats
- •6. If the patient has received prior JAK2 inhibitor treatment, this treatment must meet at least one of the following criteria:
- •- Prior treatment with any JAK2 inhibitor, irrespective of dose, with a duration of 90 days or less. The 90-day period starts on the date of first administration of JAK2 inhibitor therapy and continues for 90 calendar days, regardless of whether therapy is administered continuously or intermittently during that interval.
- •- Prior treatment with ruxolitinib, at no more than 10 mg total daily dose on any day, with a duration of 270 days or less. The 270-day period starts on the date of first ruxolitinib administration and continues for 270 calendar days, regardless of whether therapy is administered continuously or intermittently during that interval.The patient may not have received >10 mg of ruxolitinib on any day during that interval.
- •7. Eastern Cooperative Oncology Group performance status 0 to 2
- •8. Peripheral blast count of <10% throughout the Screening period and at baseline
- •9. Absolute neutrophil count of =500/µL
- •10.Left ventricular cardiac ejection fraction of =50% by echocardiogram or multigated acquisition (MUGA) scan
排除标准
- •1. Life expectancy <6 months
- •2. Completed allogeneic stem cell transplant (allo-SCT) or are eligible for and willing to complete other approved available therapy including allo-SCT
- •3. History of splenectomy or planning to undergo splenectomy
- •4. Splenic irradiation within the last 6 months
- •5. Previously treated with pacritinib
- •6. Treatment with any MF-directed therapy within 14 days prior to treatment Day 1
- •7. Any prior treatment with more than one JAK2 inhibitor
- •8. Treatment with an experimental therapy within 28 days prior to treatment Day 1
- •9. Systemic treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 (CYP450) inducer within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with approval of the Medical Monitor, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1
- •10. Significant recent bleeding history defined as National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade =2 within 3 months prior to treatment Day 1, unless precipitated by an inciting event (e.g., surgery, trauma, or injury)
研究者
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