EUCTR2016-005214-21-ES进行中（未招募）1 期
Phase Ib/II clinical trial of ruxolitinib in combination with nilotinib and prednisona for myelofibrosis: RuNiC study - RuNiC
Grupo Español de Enfermedades Mieloproliferativas GEMFI0 个研究点目标入组 44 人开始时间: 2017年5月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients are included in the study if all of the following criteria are met:
- •1.Patients must be 18 years or older.
- •2.Patients must be diagnosed with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF) irrespective of JAK2 mutation status, guided by the criteria outlined in the 2008 World Health Organization (WHO) criteria for PMF9 and the proposed criteria for PPV-MF and PET-MF outlined by the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT)10.
- •3.Patient must be classified as at least intermediate risk level 1 (1 or more prognostic factors) with at least one criteria other than age. The prognostic factors, defined by the International Working Group are11:
- •?Age > 65 years.
- •?Presence of constitutional symptoms (weight loss > 10% in the year preceding the screening visit, unexplained fever, or excessive night sweats persisting for more than 1 month).
- •?Marked anemia (hemoglobin < 10g/dL)*.
- •?Leukocytosis (history of white blood cell count > 25 x109/L).
- •?Circulating blasts = 1%.
- •*A hemoglobin value < 10 g/dL must be demonstrated during the screening for patients who are not transfusion dependent. Patients receiving regular transfusions of packed red blood cells will be considered to have hemoglobin < 10 g/dL for the purpose of evaluation of risk factors.
- •4.Patient must have palpable spleen of at least 5 cm from the costal margin to the point of greatest splenic protrusion at screening.
- •5.Patients must have active symptoms of MF as measured by the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS). Demonstrated as a minimum of 5 points in at least one item (scale 0-10), or two items of at least 3 points (scale 0-10).
- •6.Patients naïve to JAK inhibitors treatment are eligible for treatment arm A. Patients non-responding to or relapsed after JAK inhibitors treatment must meet one of the following criteria at screening to be eligible for treatment arm B (patients with prior ruxolitinib [INC424] treatment must meet one of the criteria below after at least 12 weeks on ruxolitinib treatment):
- •?Patients with no improvement in spleen length and may or may not have a corresponding symptomatic improvement.
- •?Patients with less than a 25% spleen length reduction by palpation and may or may not have a corresponding symptomatic improvement.
- •?Patients that have had a 25% to 49% reduction in spleen length by palpation and without symptomatic improvement.
- •?Patients who have lost benefit from prior treatment with a JAK inhibitor as per investigator (i.e. increased spleen length from nadir >40% as measured by palpation and/or return of symptoms as per investigator’s assessment).
- •7.Platelet counts = 50 x 109/L not reached with the aid of transfusions at screening or cycle 1 day 1.
- •8.Patients with absolute neutrophil count > 1 x 109/L at screening without the use of granulocyte colony-stimulating factors.
- •9.Fasting plasma glucose = 120 mg/dL or < 6.7 mmol/L at screening.
- •10.Serum creatinine = 2 x upper limit of normal (ULN) at screening.
- •11.Patients with peripheral blood blast count of <5% at screening.
- •12.Patients with an ECOG performance status of 0, 1, or 2 at screening.
- •13.Patients must have discontinued all drugs used to treat underlying MF disease no later than 7 days prior to screening evaluation visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (1
排除标准
- •Pregnant or nursing (lactating) women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- •-Women of child-bearing potential.
- •-Male sterilization (at least 6 months prior to screening).
- •-For female subjects on the study the vasectomized male partner should be the sole partner for that subject.
- •.Previous treatment with JAK inhibitors (including ruxolitinib [INC424]) that resulted in clinically significant toxicities at the discretion of the investigator.
- •Patient with clinically significant bacterial, fungal, parasitic or viral infection which require therapy at screening. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
- •Patients with known active hepatitis B or C or with known HIV positivity (testing is not mandatory).
- •Patients with impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of ruxolitinib, nilotinib and prednisone at screening (e.g. uncontrolled nausea, vomiting, diarrhea, mal-absorption syndrome, small bowel resection).
- •Patient with a concurrent malignancy or malignancy within 3 years of screening, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
- •Patient who has not recovered to grade 1 or better from any AEs (except alopecia, fatigue, nausea, vomiting) related to previous antineoplastic therapy before screening procedures are initiated.
- •Patients receiving the following treatments/medications:
- •An enzyme-inducing anti-epileptic drug within 2 weeks prior to starting study treatment.
- •Medication that has a known risk to prolong the QT interval or induce Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment.
- •Treatment with a potent systemic inhibitor or a potent systemic inducer of CYP3A4 at the time of screening and cannot be discontinued or switched to alternative medication prior to starting study treatment.
- •Any regular use of drugs that interferes with coagulation or inhibits platelet function. NOTE: low doses of aspirin = 150 mg/day and low molecular weight heparin are allowed.
- •Patients who have had splenic irradiation within 12 months prior to screening.
- •Patient has undergone the following invasive procedures:
- •Major surgical procedure, open biopsy or significant traumatic injury < 14 days prior to starting study drug or has not recovered from side effects of such therapy.
- •Patient has a history of cardiac dysfunction including any of the following:
- •Myocardial infarction within the past 6 months documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular ejection fraction (LVEF) function.
- •Documented congestive heart failure (New York Heart Association functional classification III-IV).
- •Documented cardiomyopathy.
- •Patient has active cardiac disease including any of the following:
- •LVEF < 50% as determined by (MUGA) or (ECHO).
- •QTc > 480 msec on screening (ECG) (QTcF, using the Fridericia formula).
- •Angina pectoris that requires the use of anti-anginal medication.
- •Ventricular arrhythmias except for benign premature ventricular contractions.
- •Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication.
- •Conduction abnormality requiring a pacemaker.
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