EUCTR2008-001361-29-GB进行中（未招募）不适用
Phase II efficacy and safety study of Dasatinib in Patients with Chronic and Accelerated Phase Chronic Myeloid Leukaemia Relapsing after Allogeneic Blood or Bone Marrow Transplantation - CML DASATINIB
EBMT (European group for Blood and Marrow Transplantation)0 个研究点目标入组 50 人开始时间: 2009年6月11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
- 入组人数
- 50
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
- •1) Male or female patients minimum 18 years of age
- •2) Diagnosed with BCR-ABL (+) Chronic Myeloid Leukemia (they can be Philadelphia chromosome positive or negative)
- •3) Prior therapy including imatinib
- •4) Patients transplanted from an HLA-identical sibling or an HLA-matched unrelated donor.
- •5) Patients transplanted in first chronic phase or accelerated phase.
- •6) Patients with untreated relapse of BCR-ABL (+) CML after allogeneic transplantation and entered within 6 weeks of the first detection of relapse.
- •7) Molecular, cytogenetic or haematological relapse in chronic or accelerated phase.
- •8) Written informed consent.
- •9) Absence of serious concomitant illness.
- •10) Negative pregnancy test for women of child bearing age
- •11) The need to be affiliated with (NATIONAL) health insurance or beneficiary of such regime
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Patients relapsing in blast crisis.
- •2) Patients transplanted after blastic transformation of CML.
- •3) Patients receiving any therapy for relapse other than withdrawal of immunosuppression (DLI is not permitted).
- •4) Patients treated with other investigational agents during the previous 30 days (list of prohibited therapies can be found in section 8.6.1).
- •5) Patients previously treated with Dasatinib.
- •6) Absence of written informed consent.
- •7)Patients incapable of giving consent personally.
- •8) Presence of serious concomitant disease.
- •9) History of a significant bleeding disorder unrelated to CML.
- •10) Pregnancy or lactation status positive.
- •11) Patients and/or female partners of male patients not using highly effective method of birth control i.e. intrauterine device (IUD), hormonal (oral pill, injection, implants), tubal ligation or partner’s vasectomy.
- •12)SGOT and SGPT more than 2.5 x the upper limit of the normal range as determined by the laboratory where the analysis is performed.
- •13) Total serum bilirubin level more than 2 x the upper limit of the normal range of the laboratory where the analysis is performed.
- •14) Serum creatinine concentration more than 1.5 x the upper limit of the normal range of the laboratory where the analysis is performed.
- •15)Concomitant Medications, any of the following should be considered for exclusion:
- •a)Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting Dasatinib):
- •i)quinidine, procainamide, disopyramide.
- •ii)amiodarone, sotalol, ibutilide, dofetilide.
- •iii)erythromycin, clarithromycin.
- •iv)chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, zyprasidone.
- •v)cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
- •b)The concomitant use of H2 blockers or proton pump inhibitors with Dasatinib is not recommended. The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving Dasatinib therapy. If antacid therapy is needed, the antacid dose should be administered at least 2 hours prior to or 2 hours after the dose of Dasatinib.
研究者
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