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 (Vestal)

Conditions

Acute Myeloid Leukemia (AML), Myleodyplastic Neoplasm/Acute Myeloid Leukemia (MDS/AML) and higher risk MDS

Brief summary

Overall Survival (OS) at day 28 after alloHCT

Detailed description

Adverse Events ≥ CTCAE grade 4, Non-relapse Mortality (NRM) at day 100 after alloHCT, Overall survival (OS) day 100 after alloHCT, Cumulative Incidence of Relapse (CIR) day 100 after alloHCT, Adverse Events ≥ CTCAE grade 3, Rate of delayed Engraftment at day 28 after alloHCT, Stage and Grade of acute GVHD at day 100 after alloHCT, Composite Complete Remission (cCR) Rate at day 100 after alloHCT by pathological assessement of bone marrow biopsy** and peripheral blood count, Rate of MRD-negativity at day 100 after alloHCT by flow cytometric assessment, Rate of MRD-negativity at day 100 after alloHCT by qPCR, Rate of complete Donor Chimersim, Rate of patients with >50/µl T-helper cells at day 100 after alloHCT by flow cytometric assessment, Health-related Quality of Life at day 100 after alloHCT assessed with FACT-BMT4 and EQ-5D- 5L-VAS5, Cumulative number of hospitalized days at day 100

Lucas Mix, Wichard Vogel, Britta Besemer, Peter Martus, Claudia Lengerke et al. (7 authors)

Blood2025-11-03

10.1182/blood-2025-6001

Interventions

DRUGTrecondi 5 g powder for solution for infusion

DRUGVenclyxto 100 mg film-coated tablets

DRUGFludarabin HEXAL® 25 mg/ml Konzentrat zur Herstellung einer Injektions- oder Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS) at day 28 after alloHCT	—

Secondary

Measure	Time frame
Adverse Events ≥ CTCAE grade 4, Non-relapse Mortality (NRM) at day 100 after alloHCT, Overall survival (OS) day 100 after alloHCT, Cumulative Incidence of Relapse (CIR) day 100 after alloHCT, Adverse Events ≥ CTCAE grade 3, Rate of delayed Engraftment at day 28 after alloHCT, Stage and Grade of acute GVHD at day 100 after alloHCT, Composite Complete Remission (cCR) Rate at day 100 after alloHCT by pathological assessement of bone marrow biopsy** and peripheral blood count, Rate of MRD-negativity at day 100 after alloHCT by flow cytometric assessment, Rate of MRD-negativity at day 100 after alloHCT by qPCR, Rate of complete Donor Chimersim, Rate of patients with >50/µl T-helper cells at day 100 after alloHCT by flow cytometric assessment, Health-related Quality of Life at day 100 after alloHCT assessed with FACT-BMT4 and EQ-5D- 5L-VAS5, Cumulative number of hospitalized days at day 100	—

Measure

Time frame

Adverse Events ≥ CTCAE grade 4, Non-relapse Mortality (NRM) at day 100 after alloHCT, Overall survival (OS) day 100 after alloHCT, Cumulative Incidence of Relapse (CIR) day 100 after alloHCT, Adverse Events ≥ CTCAE grade 3, Rate of delayed Engraftment at day 28 after alloHCT, Stage and Grade of acute GVHD at day 100 after alloHCT, Composite Complete Remission (cCR) Rate at day 100 after alloHCT by pathological assessement of bone marrow biopsy** and peripheral blood count, Rate of MRD-negativity at day 100 after alloHCT by flow cytometric assessment, Rate of MRD-negativity at day 100 after alloHCT by qPCR, Rate of complete Donor Chimersim, Rate of patients with >50/µl T-helper cells at day 100 after alloHCT by flow cytometric assessment, Health-related Quality of Life at day 100 after alloHCT assessed with FACT-BMT4 and EQ-5D- 5L-VAS5, Cumulative number of hospitalized days at day 100

—

Countries

Germany

Outcome results

None listed