Untreated patients with higher risk MDS and oligoblastic AML eligible and intended for allogeneic HCT within the next 6 months
Conditions
Brief summary
EFS with a data cut off date of September 2025
Detailed description
Best and overall response rate according to AML-ELN and MDS-IWG criteria, Toxicity as measured by NCI CTCAE v5.0, Proportion of patients proceeding to alloHCT, MRD assessed at all times of BM puncture, Quality of life as measured by EORTC-QLQ30 supplemented by information on self-assessed concomitant diseases and demographics upon inclusion and at EOT (i.e. before alloHCT, if applicable), Key Secondary Endpoint: OS with a data cut-off dates of September 2025 for interim and September 2026 for final
Interventions
DRUGAZACITIDINE
DRUGDAUNORUBICIN HYDROCHLORIDE
DRUGCYTARABINE
Sponsors
GWT-Tud GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFS with a data cut off date of September 2025 | — |
Secondary
| Measure | Time frame |
|---|---|
| Best and overall response rate according to AML-ELN and MDS-IWG criteria, Toxicity as measured by NCI CTCAE v5.0, Proportion of patients proceeding to alloHCT, MRD assessed at all times of BM puncture, Quality of life as measured by EORTC-QLQ30 supplemented by information on self-assessed concomitant diseases and demographics upon inclusion and at EOT (i.e. before alloHCT, if applicable), Key Secondary Endpoint: OS with a data cut-off dates of September 2025 for interim and September 2026 for final | — |
Countries
Austria, Germany
Outcome results
None listed