EUCTR2017-002335-42-NL进行中（未招募）1 期
A phase I/II feasibility study of the combination of panobinostat and midostaurin in recipients of allogeneic stem cell transplantation with FLT3-ITD AM
HOVON Foundation0 个研究点目标入组 40 人开始时间: 2018年1月17日最近更新:
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
- 40
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
- •Adult patients (18-70 years of age);
- •AML (except acute promyelocytic leukemia, AML M3 and bcr/abl positive AML) according to WHO 2016 classification or RAEB with IPSS-R > 4.5 with high mutant to wild-type allelic ratio of FLT3-ITD;
- •Newly diagnosed or in first relapse having obtained remission after induction chemotherapy;
- •First allogeneic HSCT scheduled within the next 2 months upon having achieved hematological remission (< 5% blasts at the bone marrow level);
- •Matched sibling or matched unrelated donor (i.e. 10/10 or 9/10 HLA-matched) or haploidentical donor;
- •Using one of the following conditioning regimens:
- •-Fludarabine/Cyclophosphamide/TBI 2 Gy in combination with post-Tx cyclophosphamide (PT-CY) only;
- •-Fludarabine/Busulfan or Melphalan/Fludarabine/TBI or fludarabin/TBI 8 Gy with post-transplant cyclophosphamide
- •or one of the alternative regimen in appendix B;
- •No history of significant cardiac disease and absence of active symptoms, otherwise documented left ventricular EF > 40%;
- •Negative serum pregnancy test for female patients of childbearing potential, at registration;
- •Female patients of childbearing potential must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment;
- •Written informed consent.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Known HIV or HCV positivity;
- •History of active malignancy during the past 2 years with the exception of basal carcinoma of the skin or carcinoma in situ” of the cervix or breast;
- •Pregnant or breast-feeding female patients.
- •Psychiatric disorder that interferes with ability to understand the study and give informed consent, and/or impacts study participation or follow-up;
研究者
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