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

NCT06429670 | Completed

• 1 other identifier: 69HCL24_0521
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Keywords

acute myeloid leukemia; azacitdine; venetoclax; MRD

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival corresponds to time to death from the initiaiton of AZA/VEN, regardless of disease recurrence.

  up to 5 months

Study Arms (1)

Azacytidine and venetoclax treated patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Every adult patients ( \>18 years old) with a diagnostic of AML treated by the association of AZACYTIDINE and VENETOCLAX between January 2019 and December 2023.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (12)

Centre Hospitalier Pierre Oudot | Groupement hospitalier Nord

Bourgoin, 38300, France

Location

METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,

Chambéry, 73000, France

Location

CHU Clermont-Ferrand Site Estaing

Clermont-Ferrand, 63100, France

Location

Centre Hospitalier Annecy Genevois

Épagny, 74370, France

Location

CHU Grenoble Alpes

La Tronche, France

Location

Centre Léon Bérard

Lyon, 69003, France

Location

Hospices Civils de Lyon

Lyon, 69229, France

Location

Centre Hospitalier de Roanne

Roanne, 42300, France

Location

CHU de Saint-Étienne Hôpital Nord

Saint-Priest-en-Jarez, 42270, France

Location

Centre Hospitalier de Valence

Valence, 26000, France

Location

Ch de Valence

Valence, France

Location

Hopital Vichy

Vichy, 03200, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 28, 2024
• Study Start: May 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)