A study about the treatment of patients with a specific type of AML with a combination of panobinostat and midostaurin during 1 year after allogeneic stem cell transplantation .

Phase 1

• Conditions: adverse risk AML or RAEB; MedDRA version: 20.0Level: LLTClassification code 10001941Term: AMLSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10037803Term: RAEBSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002335-42-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-17
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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 clinical trial of medicinal product
• Study Design: Not specified