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

Minimal Residual Disease Clinical Trial

Official title:

A Multicentric, Prospective Study Addressing the Kinetics and Impact on Survival of Measurable Residual Disease in Acute Myeloid Leukemia Patients Receiving Azacitidine and Venetoclax

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06090786
• Other study ID #: AML2723
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Paola Fazi
• Phone: 0670390528
• Email: p.fazi[@]gimema.it
• Is FDA regulated: No
• Study type: Interventional

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

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AML, Adult
• Minimal Residual Disease
• Neoplasm, Residual

Intervention

Diagnostic Test:
• MRD assessment
Bone marrow withdrawal for MRD quantification

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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