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Preemptive treatment with venetoclax plus azacitidine in patients diagnosed with acute myeloid leukemia (AML) with persistence or reappearance of measurable residual disease (MRD) after frontline chemotherapy and high-level MRD prior to allogeneic hematopoietic cell transplantation (alloHCT)

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510648-29-00
Acronym
CETLAM-LMA-AC-202401
Enrollment
29
Registered
2024-08-14
Start date
2024-12-12
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Rate of MRD conversion after 2 to 4 courses of Ven/Aza treatment.

Secondary

MeasureTime 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

Source: EU CTIS · Data processed: Feb 4, 2026