Kinetics and Impact on Survival of MRD in AML Patients Re... | NCT06090786

Studies
Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax

NCT06090786

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status

Not yet recruiting

Last Update Posted

Apr 10, 2024Actual

Enrollment

225Estimated

Phase

Not Applicable

Conditions

AML, Adult
Minimal Residual Disease

Interventions

MRD assessment

Countries

Not provided

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2024Estimated

Primary Completion Date

Jul 2027Estimated

Completion Date

Jul 2027Estimated

First Submitted Date

Oct 13, 2023

First Submission Date that Met QC Criteria

Oct 13, 2023

First Posted Date

Oct 19, 2023Actual

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

Apr 9, 2024

Last Update Posted Date

Apr 10, 2024Actual

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 no-profit, multicenter, biological, non-pharmacologic study is to evaluate minimal residual disease (MRD) in patients treated with Azacitidine and Venetoclax according to clinical practice.

The main questions it aims to answer are:

kinetics of disease response on treatment with Azacitidine and Venetoclax through the evaluation of MRD with both cytofluorimetric and molecular techniques
impact of MRD on survival outcomes. To this end, bone marrow samples will be collected at pre-defined time-points during treatment and MRD will be assessed.

Detailed Description

This is a multicentric biological study at evaluating MRD kinetics during treatment with Azacitidine and Venetoclax as well as the impact of MRD on survival outcomes.

Newly diagnosed, previously untreated, patients with AML, including de novo, secondary and therapy-related, receiving front-line therapy with Azacitidine and Venetoclax according to clinical practice will be included.

Response assessment will be performed on BM aspirate according to ELN2022 response criteria. MRD evaluation will be performed on BM at pre-defined time-points during treatment. MRD assessment will be performed centrally in order to harmonize response evaluation.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

225Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRD evaluation	Other	Evaluation of MRD at pre-defined timepoints in AML patients treated with Azacitidine and Venetoclax	Diagnostic Test: MRD assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRD assessment	Diagnostic Test	Bone marrow withdrawal for MRD quantification	MRD evaluation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of MRD-negative patients within cycle 4	Number of patients without minimal residual disease within cycle 4 on the total of subjects receiving at least one dose of study medication	4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must be ≥ 18 years of age
Subject has diagnosis of AML according to WHO 2016
Subject has newly diagnosed, previously untreated, AML, including de novo, secondary and therapy-related (cytoreduction with hydroxyurea is admitted prior treatment start)
Subject is planned to receive front-line therapy with Azacitidine and Venetoclax
Subject is ineligible for intensive induction chemotherapy according to investigator assessment according to clinical practice
Subject must have assessable MRD by flow cytometry at screening BM evaluation
Signed written informed consent according to ICH/EU/GCP and national local laws

Exclusion Criteria:

Diagnosis of BCR::ABL1-positive AML
Diagnosis of APL
AML with CNS involvement.
AML with extra-medullary localizations
Patients' unwillingness or inability to comply with the protocol requirements.

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
Paola Fazi	Contact	0670390528		p.fazi@gimema.it
Enrico Crea	Contact	0670390514		e.crea@gimema.it

Overall Officials

Name	Affiliation	Role
Antonio Curti	Division of Hematology IRCCS Azienda Ospedaliero-Universitaria di Bologna	Principal Investigator

Locations

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D018365	Neoplasm, Residual

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided