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New treatment option for AML, Adult
Official title Venetoclax-Decitabine in Untreated Elderly/Unfit AML
ClinicalTrials.gov ID: NCT07117422
What this study is testing
What is VEN + DEC?
VEN + DEC is an investigational medicine, being studied as a potential treatment for aml, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Acute myeloid leukemia (AML) is a highly fatal malignancy in China, with particularly poor outcomes in elderly patients. Low-intensity regimens yield low remission rates, and median overall survival (OS) typically remains under 6-9 months.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Patients meeting the World Health Organization (WHO) 2022 diagnostic criteria for acute myeloid leukemia (AML), excluding:Acute promyelocytic...
- Patients classified as AML, not otherwise specified (NOS) per WHO criteria, excluding:Acute panmyelosis with myelofibrosis 、Myeloid sarcoma
- Age and fitness criteria: -Group A: Age ≥65 years (unwilling to receive intensive chemotherapy) Group B: Age \>18 years and ineligible for...
- No prior AML therapy, except:Hydroxyurea、Low-dose cytarabine (\<1.0 g/day)
- ECOG performance status ≤3
You likely can't join if
- AML with BCR::ABL1 fusion or chronic myeloid leukemia (CML) in blast crisis.
- Previously treated AML patients (received prior induction chemotherapy, regardless of response).
- Secondary AML, including:Therapy-related AML (per WHO classification)、AML with prior history of myelodysplastic syndrome (MDS) or myeloproliferative...
- Concurrent hematologic disorders (e.g., hemophilia, myelofibrosis, or other conditions deemed ineligible by the investigator). Exception: Patients...
- Pregnant or lactating women.
- Hypersensitivity to any study drugs.
See the full eligibility criteria
- Patients meeting the World Health Organization (WHO) 2022 diagnostic criteria for acute myeloid leukemia (AML), excluding:Acute promyelocytic leukemia (APL) AML with recurrent genetic abnormalities...
- Patients classified as AML, not otherwise specified (NOS) per WHO criteria, excluding:Acute panmyelosis with myelofibrosis 、Myeloid sarcoma
- Age and fitness criteria: -Group A: Age ≥65 years (unwilling to receive intensive chemotherapy) Group B: Age \>18 years and ineligible for standard-dose chemotherapy, defined by ≥1 of the following:ECOG performance...
- No prior AML therapy, except:Hydroxyurea、Low-dose cytarabine (\<1.0 g/day)
- ECOG performance status ≤3
- Laboratory requirements (within 7 days prior to treatment):AST/ALT/ALP ≤3×ULN (≤5×ULN if due to leukemic involvement)、Total bilirubin ≤2×ULN、Cardiac enzymes \<2×ULN、Serum creatinine clearance ≥30 mL/min (measured or...
- Contraception requirements:Negative pregnancy test (within 72 hours before treatment) for women of childbearing potential；Agreement to use effective contraception during treatment and for 3 years after therapy
- Life expectancy ≥2 months
- Informed consent:Signed by patient, legal guardian, or immediate family member (if patient is unable to consent due to medical condition)
- AML with BCR::ABL1 fusion or chronic myeloid leukemia (CML) in blast crisis.
- Previously treated AML patients (received prior induction chemotherapy, regardless of response).
- Secondary AML, including:Therapy-related AML (per WHO classification)、AML with prior history of myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN)
- Concurrent hematologic disorders (e.g., hemophilia, myelofibrosis, or other conditions deemed ineligible by the investigator). Exception: Patients with prior blood count abnormalities but confirmed non-MDS/MPN by bone...
- Pregnant or lactating women.
- Hypersensitivity to any study drugs.
- Use of strong/moderate CYP3A4 inducers within 3 days prior to treatment initiation.
- Active malignancy in other organs (requiring treatment).
- Clinically significant hepatic/renal dysfunction exceeding inclusion criteria limits.
- Active cardiac disease, defined as ≥1 of the following:Myocardial infarction within 6 months before enrollment；History of symptomatic arrhythmia requiring medication；Uncontrolled/symptomatic congestive heart failure...
- Active infections, including:Untreated tuberculosis or pulmonary aspergillosis Known HIV, active hepatitis B (HBV), or hepatitis C (HCV)
- Central nervous system (CNS) leukemia at baseline.
- Medical history of:Epilepsy requiring medication、Dementia or psychiatric disorders impairing protocol compliance
- Conditions limiting oral drug absorption (e.g., malabsorption syndrome).
- Investigator's discretion for ineligibility.
The study team makes the final eligibility decision.
Where it's taking place
- Hebei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hebei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.