## Protocol Section
### Identification Module
**NCT ID:** NCT06429670

**Acronym:** VENAURA

**Brief Title:** Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory

**Official Title:** Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory Settings: a Multicentric Study From French AURAML Group

#### Organization Study ID Info
**ID:** 69HCL24_0521
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2023-09-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-07-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospices Civils de Lyon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Acute Myeloid Leukemia

**Keywords:**

- acute myeloid leukemia

- azacitdine

- venetoclax

- MRD

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 500

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Label:** Azacytidine and venetoclax treated patients

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Overall survival

**Time Frame:** up to 5 months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bourgoin-Jallieu

**Country:** France

**Facility:** Centre Hospitalier Pierre Oudot | Groupement hospitalier Nord

**Zip:** 38300

**Location 2:**

**City:** Chambéry

**Country:** France

**Facility:** METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,

**Zip:** 73000

**Location 3:**

**City:** Clermont-Ferrand

**Country:** France

**Facility:** CHU Clermont-Ferrand Site Estaing

**Zip:** 63100

**Location 4:**

**City:** La Tronche

**Country:** France

**Facility:** CHU Grenoble Alpes

**Location 5:**

**City:** Lyon

**Country:** France

**Facility:** Centre Léon Bérard

**Zip:** 69003

**Location 6:**

**City:** Lyon

**Country:** France

**Facility:** Hospices Civils de Lyon

**Zip:** 69229

**Location 7:**

**City:** Roanne

**Country:** France

**Facility:** Centre Hospitalier de Roanne

**Zip:** 42300

**Location 8:**

**City:** Saint-Priest-en-Jarez

**Country:** France

**Facility:** CHU de Saint-Étienne Hôpital Nord

**Zip:** 42270

**Location 9:**

**City:** Valence

**Country:** France

**Facility:** Centre Hospitalier de Valence

**Zip:** 26000

**Location 10:**

**City:** Valence

**Country:** France

**Facility:** Ch de Valence

**Location 11:**

**City:** Vichy

**Country:** France

**Facility:** Hopital Vichy

**Zip:** 03200

**Location 12:**

**City:** Épagny

**Country:** France

**Facility:** Centre Hospitalier Annecy Genevois

**Zip:** 74370

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: HIGH

- As Found: Leukemia

- ID: M10955

- Name: Leukemia, Myeloid

- Relevance: HIGH

- As Found: Myeloid Leukemia

- ID: M18127

- Name: Leukemia, Myeloid, Acute

- Relevance: HIGH

- As Found: Acute Myeloid Leukemia

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3995

- Name: Myeloid Leukemia

- Relevance: HIGH

- As Found: Myeloid Leukemia

- ID: T182

- Name: Acute Myeloid Leukemia

- Relevance: HIGH

- As Found: Acute Myeloid Leukemia

- ID: T188

- Name: Acute Non Lymphoblastic Leukemia

- Relevance: HIGH

- As Found: Acute Myeloid Leukemia

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007938

- Term: Leukemia

- ID: D000007951

- Term: Leukemia, Myeloid

- ID: D000015470

- Term: Leukemia, Myeloid, Acute

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M249656

- Name: Venetoclax

- Relevance: LOW

- As Found: Unknown

- ID: M4673

- Name: Azacitidine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
