EUCTR2012-005010-19-GB进行中（未招募）1 期
Exploring the Potential of Dual Kinase JAK 1/2 Inhibitor Ruxolitinib (INC424) with Reduced Intensity Allogeneic Hematopoietic Cell Transplantation in Patients with Myelofibrosis - MPD-RC 114
Consorzio Mario Negri Sud0 个研究点目标入组 86 人开始时间: 2015年4月16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
- 86
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
入选标准
- •1. Documented diagnosis of primary myelofibrosis according to WHO (World Health Organisation) criteria or either post PV (polycythemia vera) myelofibrosis or post ET (essential thrombocythemia) myelofibrosis as per IWG-MRT (International Working Group-Myeloproliferative Neoplasms Research and Treatment) criteria
- •2. Age 18–70 years
- •3. Intermediate- 2 / high-risk disease as per Dynamic International Prognostic Scoring System (DIPSS) criteria
- •Intermediate- 1 risk disease with one of the following additional unfavourable features known to impact upon survival, adversely
- •a. Red cell transfusion dependency
- •b. Unfavourable Karyotype
- •c. Platelet count less than 100 x 109/L
- •4. Blasts in Peripheral Blood and Bone Marrow less than 20% prior to study enrolment
- •5. Availability of a suitable matched related (6/6 or 5/6) or unrelated donor (10/10 or 9/10 antigen or allele matched)
- •6. Able to give informed written consent
- •7. ECOG Performance status of 0-2
- •8. Life expectancy greater than 3 months
- •9. Off all MF-directed therapy including investigational agents for at least 2 weeks prior to study enrolment and recovered from all toxicities*
- •10. Adequate organ function:
- •Adequate renal function – creatinine less than 1.5 x Institutional Upper Limit of Normal (IULN)
- •Adequate hepatic function – Aspartate Aminotransferase / Alanine Aminotransferase (AST/ALT) less than 2.5 x IULN, Total Bilirubin less than 1.5 x IULN
- •Adequate hematopoietic function – Platelet greater than or equal to 50 x 109/L and Absolute Neutrophil Count greater than or equal 1.0 x 109/L
- •Left Ventricular Ejection Factor (LVEF) greater than 40% (Multiple Gated Acquisition Scan or echocardiogram) normal per institutional standard
- •Adequate pulmonary function with Diffusing capacity of Lung Carbon Dioxide (DLCO) greater than 50%
- •* A patient who has been on stable dose of Ruxolitinib and has received treatment less than or equal to 6 months prior to the study entry will be considered potentially eligible for the study with the caveat that there is no evidence of loss of response (greater than 5cm increase in spleen size from the lowest point termed 'nadir').
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •1. Any previous JAK2 inhibitor treatment prior to study enrolment, with the exception of Ruxolitinib
- •2. Hypersensitivity to JAK inhibitor
- •3. Clinical or laboratory evidence of cirrhosis
- •4. Prior allogeneic transplant for any hematopoietic disorder
- •5. Greater than 20% blast in the PB (peripheral blood)or BM (bone marrow) prior to HCT or had leukemic transformation (greater than 20% blasts in PB or BM any time prior to HCT)
- •6. Syngeneic donor
- •7. Cord Blood transplant
- •8. Active uncontrolled infection
- •9. History of another malignancy within 5-years of date of HCT except history of basal cell or squamous cell carcinoma of skin or PV or ET
- •10. Known Human Immunodeficiency Virus (HIV) positive
- •11. Pregnancy at the time of transplant
- •12. Any other concurrent illness which in Investigator’s opinion puts the patient at excessive risk of treatment related toxicities
- •13. Unable to give informed consent
- •14. Active infection with hepatitis A,B or C virus
- •15. Subjects who require therapy with a strong CYP3A4 (Cytochrome P450 3A4) inhibitor prior to enrolment to this study
研究者
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