A phase Ib feasibility study of the combination of panobinostat and midostaurin in recipients of allogeneic stem cell transplantation with FLT3-ITD AML - HOVON 148 AM

HOVO0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•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 the protocol;
•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 and all men must be willing and able to use an effective contraceptive method during the study and for a minimum of 6 months after study treatment;
•Written informed consent.

•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;

发起方

HOVO