Safety and Feasibility of a Venetoclax- Augmented Treosulfan-Based Reduced Intensity Conditioning Before Allogeneic Stem Cell Transplantation in AML, MDS/AML and Higher Risk MDS
Age between 18 and 75 years at the time of signing the Informed Consent
Patient is fluent in German
Signed written Informed Consent with the cognitive ability to understand all consequences of trial participation and to comply with all trial related procedures
Diagnosis of AML,MDS/AML (according to ICC 20226) or HRMDS (IPSS-R7 >3.5 or IPSS-M8 >0; according to ICC 20226 and IWG 20232)
APL (AML with t(15;17))
MDS/MPN (ICC 20226)
Karnofsky Performance Index <60%
Patient scheduled for haploidentical allogeneic hematopoetic stem cell transplantation or bone marrow stem cell transplantation
Single group
RIC regimen
DrugVenetoclax (Venclyxto®): 400 mg abs./d day -8 to -2, Fludarabine 30 mg/m2 BSA day -6 to day -2, Treosulfan 10 g/m2 BSA day -4 to day -2
Overall survival (OS)
Primary objective of this trial is to evaluate the feasibility and safety of the augmentation of a treosulfanbased RIC regimen for alloHCT in AML, MDS/AML and HR-MDS patients with the Bcl-2-inhibitor Venetoclax. As outlined above, the aim is to increase antileukemic acitiviy without increasing morbidity and mortality in a vulnerable patient collective. This is operationalized by the following primary endpoint: 1\) Overall survival (OS) at day 28 after alloHCT Most adverse events (AEs) due to the IMPs are expected to occur before day 0. Protacted or lateonset toxicities with potentially lethal consequences cannot be ruled out. Therefore, we regard it most suitable to evaluate overall survival at day 28 after alloHCT.
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