Novel Approaches to Target MECOM/EVI1 in AML | NCT05839392

Studies
Novel Approaches to Target MECOM/EVI1 in AML

NCT05839392

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status

Recruiting

Last Update Posted

Dec 29, 2023Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

AML, Adult

Interventions

Biological characterization of AML with MECOM or atypical 3q26 rearrangements

Countries

Italy

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

Dec 2023

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

Dec 13, 2023Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Apr 21, 2023

First Submission Date that Met QC Criteria

Apr 21, 2023

First Posted Date

May 3, 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

Dec 22, 2023

Last Update Posted Date

Dec 29, 2023Actual

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

Detailed Description

This is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by AML with MECOM or atypical 3q26 rearrangements. To this end, BM samples and formalin fixed/paraffin-embedded BM biopsies will be collected at enrolment, before and after treatment, at relapse.

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

24Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological characterization of AML with MECOM or atypical 3q26 rearrangements	Biological	Peripheral blood and bone marrow withdrawal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identification of MECOM/EVI1 regulators or downstream effectors potentially druggable	To assess the number of regulators or effectors of MECOM/EVI1	At baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AML with MECOM or atypical 3q26 rearrangements.
Age ≥18.
Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

None

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
Giovanni Roti	Department of Medicine and Surgery, University of Parma, Parma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ematologia	Recruiting	Piacenza			Italy

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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074008	MDS1 and EVI1 Complex Locus Protein

Ancestor Terms

ID	Term
D004268	DNA-Binding Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011518	Proto-Oncogene Proteins

Browse Leaves

Not provided

Browse Branches

Not provided