NCT04116502招募中3 期
A Phase III, Randomised, Open-label, Multicenter International Trial Comparing Ruxolitinib With Either HydRoxycarbamIDe or Interferon Alpha as First Line ThErapy for High Risk Polycythemia Vera
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 586
- 试验地点
- 94
- 主要终点
- Event Free Survival (EFS)
研究概览
简要总结
The trial will be a phase III, randomised-controlled, multi-centre, international, open-label trial consisting of ruxolitinib versus best available therapy, where best available therapy is a choice of interferon alpha, any formulation permitted (IFN) or hydroxycarbamide (HC), and which will be elected by the Investigator prior to randomisation.
详细描述
The trial will be a phase III, randomised-controlled, multi-centre, international, open-label trial consisting of ruxolitinib versus best available therapy, where best available therapy is a choice of interferon alpha, any formulation permitted (IFN) or hydroxycarbamide (HC), and which will be elected by the Investigator prior to randomisation.
There will be no cross-over either between arm A and B or between therapies on Arm B
HC and IFN will be provided as best available therapy, IFN can include standard of pegylated-interferon at Investigators discretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Population:
- •High risk PV defined as WBC >11 x 10^9/l* AND at least ONE of the following
- •Age >60 years
- •Prior thrombosis or haemorrhage
- •Platelet count >1000 x 10^9/l*
- •Hypertension or diabetes requiring pharmacological therapy (*At any time since diagnosis)
- •Inclusion Criteria:
- •Patient ≥18 years of age
- •Diagnosis of PV meeting the WHO criteria within the past 15 years
- •Meets criteria of high risk* PV (see above for specific population)
- •Patients must have a screening haemoglobin of >8g/dl
- •Patients may have received antiplatelet agents and venesection
- •Patients may have received ONE cytoreductive therapy for PV less than 10 years (BUT they should not be resistant or intolerant to that therapy)
- •Able to provide written informed consent
排除标准
- •Diagnosis of PV > 15 years previously
- •Absence of JAK-2 mutation
- •Patients with any contraindications to any of the investigational medical products
- •Treatment with >1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 10 years OR resistance/intolerance to that therapy
- •Active infection including Human Immunodeficiency Virus (HIV), hepatitis B, hepatitis C, autoimmune hepatitis, Tuberculosis
- •Pregnant or lactating patients (Women of childbearing potential must have a negative urine or blood Human Chorionic Gonadotropin pregnancy test prior to trial entry)
- •Patients with lactose allergies, hypersensitivities, or rare hereditary problems, of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption
- •Patients with uncontrolled neuropsychiatric disorders
- •Patients with uncontrolled cutaneous cancers
- •Patients and partners not prepared to adopt highly effective contraception measures (if sexually active) whilst on treatment and for at least 6 months after completion of study medication
- •ECOG Performance Status Score ≥ 3
- •Uncontrolled rapid or paroxysmal atrial fibrillation, uncontrolled or unstable angina, recent (within the last 6 months) myocardial infarction or acute coronary syndrome or any clinically significant cardiac disease > NYHA ( New York Heart Association) Class II
- •Patients who have transformed to myelofibrosis
- •Previous treatment with ruxolitinib
- •Previous (within the last 12 months) or current platelet count <100 x 109/L or neutrophil count < 1 x 109/L not due to therapy
- •Inadequate liver function as defined by ALT/AST >2.0 x ULN
- •Inadequate renal function as defined by eGFR < 30 mls/min
- •Unable to give informed consent
- •Additional Exclusion Criteria for France Only
- •All women of childbearing potential (as per Appendix 8 definition)
- •No affiliation with the French healthcare system
- •Persons under psychiatric care that would impede understanding of informed consent and optimal treatment and follow-up
- •Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice)
- •Patients deprived of their liberty by a judicial or administrative decision
研究组 & 干预措施
A- Ruxolitinib
Experimental
Treatment with Ruxolitinib
干预措施: Ruxolitinib (Drug)
B- Hydroxycarbamide OR Interferon A
Active Comparator
Best Available Therapy (BAT), Treatment with hydroxycarbamide OR Interferon A
干预措施: Interferon-Alpha (Drug)
B- Hydroxycarbamide OR Interferon A
Active Comparator
Best Available Therapy (BAT), Treatment with hydroxycarbamide OR Interferon A
干预措施: Hydroxycarbamide (Drug)
结局指标
主要结局
Event Free Survival (EFS)
时间窗: the time from randomisation to the date of the first major thrombosis/haemorrhage, death,transformation to Myelodysplastic Syndromes, Acute Myeloid Leukaemia or Post-polycythemia Vera Myelofibrosis, if within the ~3 year trial period
Event Free Survival
次要结局
- Transformation to MDS and/or AML(Occurring while on treatment (over 3 years))
- Symptom burden/Quality of life (MDASI)(Questionnaires collected at baseline, weeks 12, 26, 39, 55, months 15, 18, 24, 30 and 36)
- Symptom burden/Quality of life (EQ-5D)(Questionnaires collected at baseline, weeks 12, 26, 39, 55, months 15, 18, 24, 30 and 36)
- Major haemorrhage(Occurring while on treatment (over 3 years))
- Transformation to PPV-MF(Occurring while on treatment (over 3 years))
- Health economics(At the end of the trial (trial duration of approximately 8 years))
- Change in QRisk score(Collected at baseline and years 1, 2 and 3)
- Major thrombosis(Occurring while on treatment (over 3 years))
- Spleen response(Response at 1 year post randomisation)
- Symptom burden/Quality of life (MPN-SAF)(Questionnaires collected at baseline, weeks 12, 26, 39, 55, months 15, 18, 24, 30 and 36)
- Complete Haematological remission (CHR)(1 year post-treatment)
- Peripheral blood JAK2 V617F allele burden(At baseline and annually throughout the trial (from baseline until approximately 3 years post-randomisation))
- Rates of discontinuation(From treatment prior to protocol defined 3 years)
- Rate and severity of adverse events(Continuous throughout the trial (from randomisation until approximately 3 years post-randomisation)))
- Time free from venesection(Defined as the mean time between venesections while on trial treatment (treatment duration of 3 years))
- Secondary malignancy(Occurring throughout the trial (from randomisation until approximately 3 years post-randomisation))
研究者
研究点 (94)
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