Acute Myeloid LeukemiaPhase 2NCT06046313
Prolonged Ultra Low-dose Decitabine Plus Venetoclax for Primary Diagnosed Elderly AMLK/MDS
A Phase 2 study testing Decitabine for Injection and VENCLYXTO in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
To explore the efficacy and safety of prolonged low-dose decitabine (10 days of 6mg/m2) plus venetoclax (3 weeks/cycle) regimen in primary diagnosed elderly or frail AML/ high-risk MDS. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Decitabine for Injection and VENCLYXTO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2023to 19 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be diagnosed with acute myeloid leukemia (non-acute promyelocytic leukemia)/high-risk myelodysplastic syndrome before admission.
- Diagnostic criteria refer to 2016 WHO classification.
- Age 60 or older.
- The scores of physical fitness in the Eastern Tumor Cooperative group (ECOG) ranged from 0 to 3(see Appendix 1).
- Creatinine clearance ≥30 mL/min(as assessed by the Cockcrod-Gault formula [Cockcroft et al 1976] [13] or the estimated glomerular filtration rate [eGFR] from the Kidney Drink adjustment formula .
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN.
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- Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50% (AHA 2016).
- Life expectancy >8 weeks.
- Sign the informed consent voluntarily, and understand and comply with the requirements of the study.
Who cannot join
- Age <60 years old.
- Treated patients who had received various chemotherapy regiments.
- Present clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional scale (see Appendix 2), or history of myocardial infarction in the 6 months prior to screening.
- Other serious diseases that may limit participation in the trial (e.g. advanced infections, uncontrolled diabetes).
- Those who cannot understand and follow the research plan or sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Weiyan Zheng, MD, 86-13857187088, zhengwy2015@163.com
Weiyan Zheng, MD
About this study
Official title: A Multi-center Prospective Single Arm Clinical Study of Prolonged Ultra Low-dose Decitabine Combined With Venetoclax (Bcl-2 Inhibitor) as First Line Treatment for Elderly Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes
To explore the efficacy and safety of prolonged low-dose decitabine (10 days of 6mg/m2) plus venetoclax (3 weeks/cycle) regimen in primary diagnosed elderly or frail AML/ high-risk MDS.
Read the detailed description
Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) are hematological malignancies. Some patients are over 65 years old, have poor response to traditional chemotherapy, and rarely have the opportunity to receive allogeneic hematopoietic stem cell transplantation, resulting in poor prognosis and short survival.
In recent years, with the advent of molecular targeted drugs Bcl-2 inhibitors, the treatment of elderly AML/ high-risk MDS has achieved breakthrough progress. In particular, the combination of demethylated drugs (decitabine/azacidacidin) and Bcl-2 inhibitors of chemotherapy-free regimen has been recommended by NCCN as the first-line treatment for elderly and frail patients.
However, how to achieve the optimal combination of decitabine and Bcl-2 inhibitors is an urgent problem to be solved.
Our previous pilot trial showed that prolonged low-dose decitabine combined with venetoclax (Bcl-2 inhibitor) resulted in higher complete remission rate, longer disease-free survival, and lower treatment-related risks.
The purpose of this study was to expand the multi-center sample to explore the efficacy and safety of prolonged low-dose decitabine plus venetoclax regimen in primary diagnosed elderly or frail AML/ high-risk MDS.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- Decitabine for Injection, VENCLYXTO
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decitabine for InjectionDrug
Also called Dacogen, 5-Aza-29-deoxycytidine
6mg/m2, ivgtt qd d1-10
VENCLYXTODrug
Also called VENLEXTA
100mg p.o.d1, 200mg p.o.d2, 400mg p.o.d3-21,adjust by blood concentration
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Acute Myeloid Leukemia Myelodysplastic Syndrome Receives: Drug: Decitabine for Injection; Drug: VENCLYXTO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate(CR+CRi)
Assessment of CR(CR=CR+CRi) at Week 8
Measured: at Week 8
Secondary outcomes (3)
MRD
Assessment of minimal residual disease (MRD) at Week 8
Measured: at Week 8
EFS
Evaluation of Event-free survival (EFS)
Measured: up to 2 years after induction therpy
OS
Evaluation of overall survival (OS)
Measured: up to 2 years after induction therpy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start19 Oct 2023
- Primary completion19 Oct 2025 (estimated)
- Study completion19 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiyan Zheng, First Affiliated Hospital of Zhejiang University
- Investigators
- Weiyan Zheng, MD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046313
- Sponsor's protocol ID
- IIT202300032C
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Single Arm Clinical Study of Prolonged Ultra Low-dose Decitabine Combined With Venetoclax (Bcl-2 Inhibitor) as First Line Treatment for Elderly Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT06046313
- Acronym / sponsor ID
- IIT202300032C
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 19 Oct 2025 (estimated)
- Study completion
- 19 Oct 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
To explore the efficacy and safety of prolonged low-dose decitabine (10 days of 6mg/m2) plus venetoclax (3 weeks/cycle) regimen in primary diagnosed elderly or frail AML/ high-risk MDS.
Detailed description
Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) are hematological malignancies. Some patients are over 65 years old, have poor response to traditional chemotherapy, and rarely have the opportunity to receive allogeneic hematopoietic stem cell transplantation, resulting in poor prognosis and short survival.
In recent years, with the advent of molecular targeted drugs Bcl-2 inhibitors, the treatment of elderly AML/ high-risk MDS has achieved breakthrough progress. In particular, the combination of demethylated drugs (decitabine/azacidacidin) and Bcl-2 inhibitors of chemotherapy-free regimen has been recommended by NCCN as the first-line treatment for elderly and frail patients.
However, how to achieve the optimal combination of decitabine and Bcl-2 inhibitors is an urgent problem to be solved.
Our previous pilot trial showed that prolonged low-dose decitabine combined with venetoclax (Bcl-2 inhibitor) resulted in higher complete remission rate, longer disease-free survival, and lower treatment-related risks.
The purpose of this study was to expand the multi-center sample to explore the efficacy and safety of prolonged low-dose decitabine plus venetoclax regimen in primary diagnosed elderly or frail AML/ high-risk MDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Decitabine for Injection, Drug: VENCLYXTOAcute Myeloid Leukemia Myelodysplastic Syndrome |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be diagnosed with acute myeloid leukemia (non-acute promyelocytic leukemia)/high-risk myelodysplastic syndrome before admission.
- Diagnostic criteria refer to 2016 WHO classification.
- Age 60 or older.
- The scores of physical fitness in the Eastern Tumor Cooperative group (ECOG) ranged from 0 to 3(see Appendix 1).
- Creatinine clearance ≥30 mL/min(as assessed by the Cockcrod-Gault formula [Cockcroft et al 1976] [13] or the estimated glomerular filtration rate [eGFR] from the Kidney Drink adjustment formula .
Key exclusion criteria (5 listed)
- Age <60 years old.
- Treated patients who had received various chemotherapy regiments.
- Present clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional scale (see Appendix 2), or history of myocardial infarction in the 6 months prior to screening.
- Other serious diseases that may limit participation in the trial (e.g. advanced infections, uncontrolled diabetes).
- Those who cannot understand and follow the research plan or sign the informed consent.
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 |
|---|---|---|
| Decitabine for InjectionAlso: Dacogen, 5-Aza-29-deoxycytidine6mg/m2, ivgtt qd d1-10 | Drug | treatment group |
| VENCLYXTOAlso: VENLEXTA100mg p.o.d1, 200mg p.o.d2, 400mg p.o.d3-21,adjust by blood concentration | Drug | treatment group |
Primary outcome
Complete response rate(CR+CRi)
Time frame: at Week 8
Assessment of CR(CR=CR+CRi) at Week 8
3 secondary outcomes
MRD
Time frame: at Week 8
EFS
Time frame: up to 2 years after induction therpy
OS
Time frame: up to 2 years after induction therpy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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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. This study is not recruiting at the moment.
Weiyan Zheng, MD principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decitabine for Injection and VENCLYXTO in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by First Affiliated Hospital of Zhejiang 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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiyan Zheng, MD (86-13857187088, zhengwy2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate(CR+CRi) (time frame: at Week 8). 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 5 Mar 2024.