EUCTR2010-019673-15-IT进行中（未招募）不适用
A open label, phase 2, non randomized, multicentre trial to assess the feasibility of induction treatment with 5-azacitidine (5-AZA) followed by allogeneic stem cell transplantation (allo-SCT) or continued 5-AZA treatment in patients without a suitable -sibling or unrelated- stem cell donor with IPSS Int-2/High risk myelodysplastic syndromes (MDS) - BMT-AZA
niversit? Cattolica del Sacro Cuore0 个研究点开始时间: 2010年7月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Have a diagnosis of myelodysplastic syndrome (MDS) according to the WHO classification for MDS (Appendix F) with a intermediate-2 or high IPSS score (score = 1.5, Appendix G) or a diagnosis of CMMoL according to the FAB classification (appendix B) with 10-20% BM or PB blasts and WBC < 20 x 109/L (preliminary cytoreduction using hydroxyurea is allowed); • Age =18 to 65 years; • Potential candidates for HSCT • life expectancy =3 months; • Signed written informed consent according to IGH/EU/GCP and national local laws; • Eastern Cooperative Oncology Group Performance Status Grade of 0-2 (Appendix I); • Serum bilirubin levels =1.5 x the upper limit of the normal (ULN) range for the laboratory; higher levels are acceptable if these can be attributed to active hemolysis (as indicated by positive direct Coombs’ testing, decreased haptoglobin level, elevated indirect bilirubin and/or lactate dehydrogenase), or ineffective erythropoiesis (as indicated by bone marrow findings). The decision of including these patients into the study will be under the responsibility of the study chairman (waiver for enrollment). • Serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum glutamic-pyruvic transaminase (alanine aminotransferase) levels =2 x ULN; • Women of childbearing potential may participate, providing they meet the following conditions: - Must not start a pregnancy throughout the study and for 6 months following the date of the last dose of study medications; - Must have a negative serum pregnancy test obtained within 48 hours prior to Day 1. • Males with female partner of childbearing potential must avoid fathering throughout the study and for 6 months following the date of the last dose of study medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-acute myeloid leukaemia;
- •-concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma);
- •-severe renal impairment (creatinine clearance <30 ml/min);
- •-severe congestive heart failure (EF =50% ) or unstable cardiac disease (NYHA 3-4);
- •-severe pulmonary disease (DLCO and/or FEV1 =65% or dyspnea at rest or requiring oxygen);
- •-pregnant or lactating or potentially fertile (both males and females), who have not agreed to avoid pregnancy during the trial period;
- •-liver disease characterized by AST and ALT level >2 x ULN and total bilirubin >1.5 x ULN (unless due to active hemolysis or ineffective erythropoiesis;
- •-HIV infection;
- •-active, uncontrolled HCV or HBV infections or liver cirrhosis;
- •-clinically relevant neurological diseases;
- •-psychiatric illness that would prevent granting of informed consent;
- •-hypersensitivity (known or suspected) to Azacitidine or Mannitol;
- •-prior Treatments: Prior investigational drugs (within 30 days)
- •Radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months
- •Growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days
- •Androgenic hormones during the previous 14 days
- •Prior transplantation or cytotoxic therapy, including azacitidine and chemotherapy, administered to treat MDS.
研究者
相似试验
进行中（未招募）
1 期
Pembrolizumab in combination with Electrochemotherapy in patients with unresectable melanomanresectable melanoma with superficial or superficial and visceral metastasesMedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864EUCTR2016-004154-15-ITISTITUTO EUROPEO DI ONCOLOGIA53
进行中（未招募）
不适用
A multicenter, open label, non-randomised phase II study with induction chemotherapy with Cisplatin and 5-fluorouracil as combined with accelerated radiotherapy and Erbitux for locally advanced unresectable squamous cell carcinomaPatient with locally advanced non-resectable squamous cell carcinoma of the head and neck stage III or IV, oral, oropharyngeal, laryngeal or hypopharyngeal cancer, non-resectable.EUCTR2006-002187-25-SERadiumhemmet, Karolinska University Hospital90
进行中（未招募）
不适用
Phase II multicenter, open label, non-randomized study of intravenous RPR109881 q 3 weeks in patients with metastatic breast cancer progressing after therapy with anthracyclines, taxanes, and capecitabine. - Not applicableMetastatic breast cancer patients after failure to anthracyclines, taxanes and capecitabine.Classification code 10055113EUCTR2004-000572-14-DKAventis Pharmaceuticals, Inc. (a subsidiary of sanofi-aventis group)162
进行中（未招募）
1 期
Phase II multicenter, open label, non-randomized study of intravenous RPR109881 q 3 weeks in patients with metastatic breast cancer progressing after therapy with anthracyclines, taxanes, and capecitabine. - Not applicableMetastatic Breast Cancer Patients after failure to Anthracyclines, Taxanes and Capecitabine.Classification code 10055113EUCTR2004-000572-14-ESAventis Pharmaceuticals, Inc.162
进行中（未招募）
不适用
Phase II multicenter, open label, non-randomized study of intravenous RPR109881 q 3 weeks in patients with metastatic breast cancer progressing after therapy with anthracyclines, taxanes, and capecitabine. - Not applicableEUCTR2004-000572-14-BEAventis Pharmaceuticals, Inc. (a subsidiary of sanofi-aventis group)162