NL-OMON47477招募中2 期
A phase II trial in patients with myelofibrosis (primary, post-ET or post PV-MF) treated with the selective JAK2 inhibitor Pacritinib before reduced-intensity conditioning allogeneic stem cell transplantation - HOVON 134 MF
HOVO0 个研究点目标入组 65 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
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 64（—）
入选标准
- •- Patients with a confirmed diagnosis of post-ET, post-PV or primary
- •myelofibrosis
- •- Intermediate-2 or high-risk according to DIPSS plus
- •- Age 18-70 years inclusive
- •- WHO performance status 0-2
- •- Platelet count >= 25 × 109/L without platelet support within 2 weeks before
- •study entry.
- •- All men and women of childbearing potential must agree to use adequate
- •contraception during the study
- •- Written informed consent
- •- Patient is capable of giving informed consent
排除标准
- •- Patients who have been treated with pacritinib as their previous JAK2
- •inhibitor treatment cannot participate in this study.
- •- Previous treatment with JAK2 inhbitors, other than pacritinib, is allowed
- •with the exception of high dose ruxolitinib (above 10 mg BID). For these
- •patients taper the dose to 10 mg BID or lower at least 2 weeks before
- •pacritinib treatment is allowed.
- •- Any GI or metabolic condition (e.g. inflammatory or chronic functional bowel
- •disorder such as Crohn*s Disease, Inflammatory Bowel Disease, chronic diarrhea
- •or constipation) that could interfere with absorption of oral medication
- •- Left ventricular cardiac ejection fraction of <= 45% by echocardiogram or
- •multigated acquisition (MUGA) scan
- •- Impaired liver and renal function, defined by liver transaminases (aspartate
- •aminotransferase [AST]/serum glutamic oxaloacetic transaminase [SGOT] and
- •alanine aminotransferase [ALT]/serum glutamic pyruvic transaminase [SGPT]), >3
- •× the upper limit of normal (ULN) (AST/ALT >5 × ULN if transaminase elevation
- •is related to MF), direct bilirubin >4× ULN, and creatinine clearance * 40
- •- Impaired coagulation function, defined by prothrombin time (PT)/international
- •normalized ratio (INR), partial thromboplastin time (APTT)>1.5 x ULN.
- •- Experimental treatment within four weeks before inclusion for PMF, Post-PV,
- •or Post-ET MF
- •- Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D)
- •- Treatment with a potent strong CYP3A4 inhibitor or a strong cytochrome P450
- •(CYP450) inducer within the last 2 weeks
- •- Treatment with anticoagulation or antiplatelet agents, except for aspirin
- •dosages of <=100 mg per day, within the last 2 weeks
- •- New York Heart Association Class II, III, or IV congestive heart
- •- QTc prolongation >450 ms as assessed by ECG and corrected by Federicia method
- •or other factors that increase the risk for QT interval prolongation (e.g.,
- •heart failure, hypokalemia [defined as serum potassium <3.0 mEq/L that is
- •persistent and refractory to correction], family history of long QT interval
- •syndrome, or concomitant use of medications that may prolong QT interval)
- •- Significant recent bleeding history defined as NCI CTCAE grade >=2 within the
- •last 3 months, unless precipitated by an inciting event (e.g., surgery, trauma,
- •- Any history of CTCAE grade >=2 non-dysrhythmia cardiac conditions within the
- •last 6 months. Patients with asymptomatic grade 2 non-dysrhythmia cardiac
- •conditions may be considered for inclusion, with the approval of the principal
- •investigator, if stable and unlikely to affect patient safety.
- •- Any history of CTCAE grade *2 cardiac dysrhythmias within the last 6 months.
- •Patients with non-QTc CTCAE grade 2 cardiac dysrhythmias may be considered for
- •inclusion, with the approval of the principal investigator, if the dysrhythmias
- •are stable, asymptomatic, and unlikely to affect patient safety.
- •- Patients with active, uncontrolled infections
- •- Patients known to be HIV (human immunodeficiency virus)-positive
- •- Active hepatitis A, B or C
- •- History of active malignancy during the past 3 years, except basal carcinoma
- •of the skin or stage 0 cervical carcinoma
- •- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled
- •diabetes, infection, hypertension, cancer, etc.)
- •- Pregnant or breastfeed
研究者
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不适用
A phase II trial in patients with myelofibrosis (primary, post-ET or post PV-MF) treated with the selective JAK2 inhibitor Pacritinib before reduced-intensity conditioning allogeneic stem cell transplantatioNL-OMON21596HOVON<br>VU University Medical Center,<br>P.O.Box 7057<br>1007 MB Amsterdam<br>The Netherlands<br>tel: +31 20 4442124<br>tel: +31 20 4449086<br>Fax: +31 20 444356670
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