AML, AdultNCT07117422
Venetoclax-Decitabine in Untreated Elderly/Unfit AML
A study testing VEN + DEC in people with AML, Adult, run by The Second Hospital of Hebei Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- AML, Adult
- What is being tested?
- VEN + DEC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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, including:t(8;21)(RUNX1::RUNX1T1)
- inv(16)(p13.1q22) or t(16;16)(p13.1q22)/CBFβ::MYH11
- 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)
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- Group B: Age >18 years and ineligible for standard-dose chemotherapy, defined by ≥1 of the following:ECOG performance status 2 or 3；History of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) ≤50% DLCO ≤65% or FEV1 ≤65%Creatinine clearance ≥30 mL/min but ≤45 mL/min (Cockcroft-Gault or 24-hour urine collection)、Any other condition deemed incompatible with standard chemotherapy (requires PI approval)
- 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 calculated)
- 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)
Who cannot join
- 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 marrow examination may be included.
- Pregnant or lactating women.
- Hypersensitivity to any study drugs.
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- 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 (NYHA Class >2)
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Hebei Medical University
Hebei
LING XI GUO, 86-13932113351, guoxiaoling@hebmu.edu.cn
About this study
Official title: Efficacy and Safety of Venetoclax Plus Decitabine in Elderly/Unfit Patients With Newly Diagnosed AML: A Multicenter Single-Arm Study
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. Venetoclax (VEN) combined with hypomethylating agents (azacitidine or decitabine（DEC）) has emerged as a first-line therapy for these patients, significantly improving response rates and survival. However, challenges persist, including suboptimal complete remission (CR) rates, low Measurable Residual Disease（MRD） negativity, and tolerability issues with prolonged use.
Recent studies suggest that a 3-day decitabine regimen combined with VEN may enhance efficacy and tolerability. Building on prior evidence and our institutional experience, we propose this study to evaluate an optimized dosing strategy of VEN plus decitabine in treatment-naïve elderly or chemotherapy-ineligible AML patients, aiming to further improve clinical outcomes.
- Conditions
- AML, Adult
- Being tested
- VEN + DEC
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEN + DECDrug
Induction regimen
Venetoclax (VEN): Day1-10
Decitabine (DEC):20mg/m²/day, Day 2-4
20mg/m² every 8 hours, Day 5-6
FLT3 Inhibitors (for FLT3/ITD+ patients only):
Sorafenib or Gilteritinib, Day 8-14
Post-Remission Treatment
Venetoclax (VEN): 400 mg/day, Day 1-7
Decitabine (DEC): 20 mg/m² every 8 hours, Day 2-3 (Regimen repeated every 4-6 weeks)
FLT3 Inhibitors (for FLT3/ITD+ patients only):
Sorafenib or Gilteritinib, Day 8-14
| Study group | Role | What they receive |
|---|---|---|
| VEN+DEC | Experimental | Not described Receives: Drug: VEN + DEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Complete Remission (CR) Rate after Cycle 1
Measured: up to 42 days after treatment
Secondary outcomes (3)
Overall Survival (OS)
Measured: Within 5 years after randomization
Relapse-Free Survival Rate (RFS)
Measured: Within 5 years after randomization
Cumulative incidence of relapse
Measured: Within 5 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start17 Jan 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Handan First Hospital
- Responsible party
- Sponsor
- Investigators
- LING XI GUO, Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117422
- Sponsor's protocol ID
- 2025-R010-F1
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Venetoclax Plus Decitabine in Elderly/Unfit Patients With Newly Diagnosed AML: A Multicenter Single-Arm Study
- ClinicalTrials.gov ID
- NCT07117422
- Acronym / sponsor ID
- 2025-R010-F1
- Conditions
- AML, Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- The Second Hospital of Hebei Medical UniversityUniversity, hospital or other
- Collaborators
- Handan First Hospital
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Venetoclax (VEN) combined with hypomethylating agents (azacitidine or decitabine（DEC）) has emerged as a first-line therapy for these patients, significantly improving response rates and survival. However, challenges persist, including suboptimal complete remission (CR) rates, low Measurable Residual Disease（MRD） negativity, and tolerability issues with prolonged use.
Recent studies suggest that a 3-day decitabine regimen combined with VEN may enhance efficacy and tolerability. Building on prior evidence and our institutional experience, we propose this study to evaluate an optimized dosing strategy of VEN plus decitabine in treatment-naïve elderly or chemotherapy-ineligible AML patients, aiming to further improve clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VEN+DEC | Experimental | Drug: VEN + DEC |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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, including:t(8;21)(RUNX1::RUNX1T1)
- inv(16)(p13.1q22) or t(16;16)(p13.1q22)/CBFβ::MYH11
- Patients classified as AML, not otherwise specified (NOS) per WHO criteria, excluding:Acute panmyelosis with myelofibrosis 、Myeloid sarcoma
- Age and fitness criteria:
Key exclusion criteria (16 listed)
- 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 marrow examination may be included.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VEN + DECInduction regimen Venetoclax (VEN): Day1-10 Decitabine (DEC):20mg/m²/day, Day 2-4 20mg/m² every 8 hours, Day 5-6 FLT3 Inhibitors (for FLT3/ITD+ patients only): Sorafenib or Gilteritinib, Day 8-14 Post-Remission Treatment Venetoclax (VEN): 400 mg/day, Day 1-7 Decitabine (DEC): 20 mg/m² every 8 hours, Day 2-3 (Regimen repeated every 4-6 weeks) FLT3 Inhibitors (for FLT3/ITD+ patients only): Sorafenib or Gilteritinib, Day 8-14 | Drug | VEN+DEC |
Primary outcome
the Complete Remission (CR) Rate after Cycle 1
Time frame: up to 42 days after treatment
3 secondary outcomes
Overall Survival (OS)
Time frame: Within 5 years after randomization
Relapse-Free Survival Rate (RFS)
Time frame: Within 5 years after randomization
Cumulative incidence of relapse
Time frame: Within 5 years after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LING XI GUO principal investigator
The Second Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VEN + DEC in people with AML, Adult, run by The Second Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LING XI GUO (13932113351, guoxiaoling@hebmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Complete Remission (CR) Rate after Cycle 1 (time frame: up to 42 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.