Clinical trial · Interventional
Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax
A Multicentric, Prospective Study Addressing the Kinetics and Impact on Survival of Measurable Residual Disease in Acute Myeloid Leukemia Patients Receiving Azacitidine and Venetoclax
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML, Adult | Adult Acute Myeloid Leukemia | ALIAS | 0.90 |
| Minimal Residual Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRD assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MRD evaluation
- description
- Evaluation of MRD at pre-defined timepoints in AML patients treated with Azacitidine and Venetoclax
- interventionNames
- Diagnostic Test: MRD assessment
Primary outcomes (1)
- measure
- Rate of MRD-negative patients within cycle 4
- timeFrame
- 4 months
- description
- Number of patients without minimal residual disease within cycle 4 on the total of subjects receiving at least one dose of study medication
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available