Status:
NOT_YET_RECRUITING
Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
AML, Adult
Minimal Residual Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 pra...
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 untr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT06090786
Start Date
July 1 2024
End Date
July 1 2027
Last Update
April 10 2024
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