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

NCT06090786 | Not Yet Recruiting

• 1 other identifier: AML2723
• Study Type: interventional
• Target: 225
• Locations: 0 countries
• Sites: N/A

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:

1. 1.kinetics of disease response on treatment with Azacitidine and Venetoclax through the evaluation of MRD with both cytofluorimetric and molecular techniques
2. 2.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.

Conditions

AML, Adult; Minimal Residual Disease

Keywords

Venetoclax; Azacitidine; AML; Minimal rsidual disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MRD evaluation

OTHER

Evaluation of MRD at pre-defined timepoints in AML patients treated with Azacitidine and Venetoclax

Diagnostic Test: MRD assessment

Interventions

MRD assessment DIAGNOSTIC_TEST

Bone marrow withdrawal for MRD quantification

MRD evaluation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Curti

  Division of Hematology IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

0670390528; p.fazi@gimema.it

Enrico Crea

CONTACT

0670390514; e.crea@gimema.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share