ISRCTN61925716已完成2 期
A randoMised study of best Available therapy versus JAK Inhibition in patients with high risk polycythaemia vera or essential thrombocythaemia who are resistant or intolerant to hydroxyCarbamide
niversity of Birmingham (UK)0 个研究点目标入组 306 人开始时间: 2012年4月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 306
研究概览
简要总结
2023 Results article in https://doi.org/10.1200/jco.22.01935 (added 30/06/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria for PV:
- •1. Male or female patient >=18 years of age
- •2. A confirmed diagnosis of high risk PV. High Risk is defined as ANY ONE of the following
- •2.1. Age >60 years
- •2.2. Previous documented thrombosis
- •2.3. Erythromelalgia or migraine (severe, recurrent, requiring medications, and felt to be secondary to the MPN) either after diagnosis or within 10 years before diagnosis and considered to be disease-related
- •2.4. Significant splenomegaly (i.e. > 5cm below costal margin on palpation) or symptomatic (splenic infarcts or requiring analgesia)
- •2.5. Platelets > 1000 x 10^9/L
- •2.6. Diabetes or hypertension requiring pharmacological therapy for > 6 months
- •Inclusion criteria for ET:
- •1. Male or female patient >=18 years of age
- •2. A confirmed diagnosis of high risk ET. High risk is defined as ANY ONE of the following:
- •2.1. Age > 60 years
- •2.2. Platelet count > 1500 x 10^9/L
- •2.3. Previous documented thrombosis
- •2.4. Erythromelalgia or migraine (severe, recurrent, requiring medications, and felt to be secondary to the MPN) either after diagnosis or within 10 years before diagnosis and considered to be disease-related
- •2.5. Previous haemorrhage related to ET Diabetes or hypertension requiring pharmacological therapy for > 6 months
- •3. ALL patients must also be either intolerant OR resistant to Hydroxycarbamide (HC) based on the following established criteria: Any ONE of the following:
- •3.1. Platelet count >600 x 10^9/L after 8 weeks of at least 2 g/day or maximum tolerated dose (MTD) of HC (2.5 g/day in patients with a body weight>80 kg)
- •3.2. Platelet count >400 x 10^9/L and WBC < 2.5 x 10^9/L at any dose of HC (for a period of at least 8 weeks)
- •3.3. Platelet count >400 x 10^9/L and Hb < 11 g/dl at any dose of HC (for a period of at least 8 weeks)
- •3.4. Platelet count persistently <100 x 109/L at any dose of HC (for a period of at least 8 weeks)
- •3.4. Progressive splenomegaly or hepatomegaly i.e. enlargement by more than 5cm or appearance of new splenomegaly or hepatomegaly on HC treatment
- •3.5. Not achieving the desired reduction of haematocrit or packed cell volume with the addition of HC in patients who do not tolerate frequent venesections after 8 weeks of at least 2 g/day of HC (2.5 g/day in patients with a body weight >80 kg)
- •3.6. Not achieving the desired stable reduction of WBC when leukocytes are a target of therapy after 8 weeks of at least 2 g/day or MTD of HC (2.5 g/day in patients with a body weight>80 kg)
- •3.7. Thrombosis or haemorrhage while on therapy
- •3.8. Presence of leg ulcers or other unacceptable HC-related non-haematological toxicities, such as unacceptable mucocutaneous manifestations, gastrointestinal symptoms, pneumonitis or fever at any dose of HC OR Cycling platelet counts on therapy
- •Target Gender: Male & Female ; Lower Age Limit 18 years
排除标准
- •1. Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
- •2. Patients and partners of childbearing potential not willing to use effective contraception
- •3. Eastern Cooperative Oncology Group Performance Status Scale (ECOG) Performance Status Score >= 3
- •4. Current rapid or paroxysmal atrial fibrillation
- •5. Uncontrolled or unstable angina
- •6. Recent (6 months) myocardial infarction or acute coronary syndrome or any clinically significant cardiac disease > New York Heart Association (NYHA) Class II
- •7. Previous treatment with a Janus kinase 2 (JAK2) inhibitor
- •8. Previous (within the last 12 months) or current platelet count <100 x 10^9/L or neutrophil count < 1 x 10^9/L not due to therapy
- •9. Inadequate liver function as defined by aspartate aminotransferase/alanine aminotransferase (ALT/AST) >1.5 x upper limit normal (ULN)
- •10. Inadequate renal function as defined by Glomerular filtration rate (GFR) < 15 mls/min
- •11. Unable to give informed consent
研究者
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