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Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory (VENAURA)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Acute Myeloid Leukemia

Study type

Observational

Funder types

Other

Identifiers

NCT06429670
69HCL24_0521

Details and patient eligibility

About

Azacytidine and venetoclax combination regimen (AZA/VEN) is the standard of care in frontline acute myeloid leukemia (AML) settings for unfit to intensive chemotherapy patients. AZA/VEN combination regiment was approved in France in 2021 but was already used in outlabel fashion since 2019. However, AZA/VEN is also associated with an increased hematological toxicity compared to azacytidine alone. In this context, alternative AZA/VEN regimens emerged progressively based on each physician experience and local procedures. Moreover, AZA/VEN is also recognized as a valuable therapeutic option in relapse/refractory settings. In this multicentric study, the investigators aimed to evaluate the efficacy and safety of various AZA/VEN regimen in frontline and relapse/refractory (R/R) patients diagnosed with AML in real life setting.

The investigators will retrospectively analyze clinical outcome of patients from 11 different French centers (Saint-Etienne, Clermont-Ferrand, Lyon (Hopital Lyon Sud, Centre Léon Bérard), Vichy, Annecy, Chambery, Valence, Bourgoin-Jallieu, Grenoble, Roanne) in Auvergne Rhône Alpes (AURA) region, between January 2019 and December 2023. Composite complete remission was defined as in VIALE-A trial. Measurable residual disease (MRD) negativity was defined as ≤ 10-3 by flow cytometry (on bone marrow) and/or ≤ 10-4 for NPM1 by RT-qPCR.

Enrollment

500 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • >18 years old
  • Acute myeloid leukemia patients at diagnostic, in relapse/refractory settings, or MRD relapse.
  • receiving AZA/VEN combination regimen

Exclusion criteria

  • Another VEN combination chemotherapy
  • AZA/VEN initiation prior January 2019 and after December 2023
  • Opposition to the study

Trial design

500 participants in 1 patient group

Azacytidine and venetoclax treated patients
Description:
Adult patients with acute myeloid leukemia treated by AZACYTIDINE and VENETOCLAX in frontline and relapse/refractory settings

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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