A phase Ib feasibility study of the combination of panobinostat and midostaurin in recipients of allogeneic stem cell transplantation with FLT3-ITD AM
- Conditions
- Acute myeloid leukemiaAMLMDS10024324
- Registration Number
- NL-OMON48580
- Lead Sponsor
- HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
• 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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Feasibility of protocol treatment as defined by the number of dose limiting<br /><br>toxicities (DLTs) during the first cycle of PNB/MST.</p><br>
- Secondary Outcome Measures
Name Time Method