De-Escalation Study Evaluating Venetoclax and Azacitidine... | NCT06557421

Studies
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients

NCT06557421

Sponsor

Institut Paoli-Calmettes

Status

Recruiting

Last Update Posted

Mar 13, 2026Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

Acute Myeloid Leukemia

Interventions

Venetoclax
Azacitidine

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 4, 2026Actual

Primary Completion Date

Nov 1, 2028Estimated

Completion Date

Nov 1, 2028Estimated

First Submitted Date

Aug 9, 2024

First Submission Date that Met QC Criteria

Aug 13, 2024

First Posted Date

Aug 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2026

Last Update Posted Date

Mar 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are:

Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival.
Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy.

Patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria.

Participants will:

Stop VEN-DASA treatment
Be closely monitored by regular evaluation of the disease

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VEN-AZA de-escalation	Experimental	VEN-AZA de-escalation	Drug: Venetoclax Drug: Azacitidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venetoclax	Drug	complete discontinuation of Venetoclax	VEN-AZA de-escalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease-Free Survival, measured from inclusion (VEN-AZA de-escalation) to the date of morphologic or measurable residual disease relapse or death from any cause, whichever occurs first.		24 months

Secondary Outcomes

Measure	Description	Time Frame
Absolute duration of hematologic response, defined as the time from inclusion to relapse or death.		24 months
Absolute duration of negative measurable residual disease response, defined as the time from inclusion to measurable residual disease relapse or death.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female/Male ≥ 18 years of age;
Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias;
VEN-AZA given as first-line treatment;
Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses;
Patients in first composite complete remission (CRc) defined as complete remission (CR) or CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh);
Absence of detectable minimal residual disease (MRD) performed locally (i.e. MRDneg defined as MCF MRD <0.1% of CD45 expressing cells with the target immunophenotype in bone marrow, or NPM1 or RUNX1-RUNX1T1 or CBFB-MYH11 MRD copy numbers <0.1% in the blood);
ECOG <3;
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
Affiliated to the French Social Security or beneficiary of such a health Insurance;
Signed informed consent.

Non inclusion Criteria:

VEN-AZA given as salvage therapy;
Prior allogeneic stem cell transplant;
Discontinuation of treatment because of absence or loss of response;
Patient in emergency situation or unable to give consent;
Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jihane PAKRADOUNI, PharmD,PhD	Contact	+33491223778		drci.up@ipc.unicancer.fr
Laurie-Anne GOUTY, PhD	Contact	33491223778		drci.up@ipc.unicancer.fr

Overall Officials

Name	Affiliation	Role
Sylvain GARCIAZ, MD PhD	Institut Paoli-Calmettes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Paoli-Calmettes	Recruiting	Marseille		13273	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
C579720	venetoclax
D001374	Azacitidine

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides