NCT06090786Not yet recruiting
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 · Last updated 10 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 225 (estimated)
- First submitted
- 13 Oct 2023
- Start date
- Jul 2024
- Primary completion date
- Jul 2027
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06090786
What you commit to
- Study type: Interventional
- Planned participants: 225
- From Jul 2024 to the primary completion date, Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.