an increase of MRD ≥1log10 between 2 positive samples ○ Confirmed MRD conversion of MRD negativity to MRD positivity AML during subsequent follow-up (up to 3 years after chemotherapy completion). - Cohort 2: Patients diagnosed with a non-favorable ELN AML subtype, as defined in the 2021 update on MRD guidelines elaborated by the European LeukemiaNet MRD Working Party (Heuser et al. 2021): ○ In patients with persistent low-level MRD (<2%) after consolidation chemotherapy, but who present an MRD failure by after frontline intensive chemotherapy, in first complete morphological remission but harboring detectable MRD at time of alloHCT (>0.1%)., intended to undergo alloHCT, not intended for alloHCT in first complete remission (CR1), or prior to allogeneic hematopoietic cell transplantation (alloHCT). Patients will be recruited in two independent cohorts depending on the pre-established time point for the intervention and ELN risk subtype: - Cohort 1: Patients diagnosed with a favorable European LeukemiaNet (ELN) subtype AML, Patients diagnosed with acute myeloid leukemia (AML) with persistent measurable residual disease (MRD) or MRD reappearance after frontline chemotherapy
Conditions
Brief summary
Rate of MRD conversion after 2 to 4 courses of Ven/Aza treatment.
Detailed description
Duration of MRD response: The length of time from the first obtention of MRD clearance until MRD progression., Relapse risk after intervention: The length of time from the intervention for AML until confirmed hematological relapse.
Interventions
DRUGAZACITIDINE
DRUGVenclyxto 100 mg film-coated tablets
Sponsors
Grupo Cooperativo De Estudio Y Tratamiento De Las Leucemias Agudas Y Mielodisplasias
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of MRD conversion after 2 to 4 courses of Ven/Aza treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of MRD response: The length of time from the first obtention of MRD clearance until MRD progression., Relapse risk after intervention: The length of time from the intervention for AML until confirmed hematological relapse. | — |
Countries
Spain
Outcome results
None listed