Acute Myeloid LeukemiaPhase 3NCT05264883
Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML
A Phase 3 study testing Venetoclax-Decitabine/Azacitidine-Aclarubicin Association and Venetoclax-Decitabine/Azacitidine Association in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Decitabine/Azacitidine and Aclarubicin) versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Venetoclax-Decitabine/Azacitidine-Aclarubicin Association and Venetoclax-Decitabine/Azacitidine Association
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 28 Feb 2025
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute myeloid leukemia (AML) diagnosed by bone marrow morphology and immunophenotyping (in line with WHO 2016 diagnostic criteria);
- No previous anti-acute leukemia treatment (including demethylating drugs), except hydroxyurea and Leukocyte apheresis;
- Exclude acute promyelocytic leukemia (APL) at the bone marrow morphology or molecular level;
- Age 60-80 years old;
- Aspartate aminotransferase (ALT), alanine aminotransferase (AST), and alkaline phosphatase (ALP)≤ 3×upper limit of normal (ULN), serum bilirubin≤ 1.5×ULN; serum creatinine≤ 2.0×ULN; serum heart rate≤ 2.0×ULN;
- LVEF determined by echocardiography≥ 50%;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Obtain informed consent signed by the patient or legal representative.
Who cannot join
- Acute promyelocytic leukemia, myeloid sarcoma, accelerated phase and blast of chronic myeloid leukemia;
- Patients with relapsed AML;
- Allergy to any drug involved in the program;
- Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
- The liver and kidney functions are obviously abnormal, exceeding the inclusion criteria;
- Structural heart disease, such as uncontrolled or symptomatic arrhythmia, congestive heart disease, heart failure or myocardial infarction within 6 months prior to screening, resulting in clinical symptoms or abnormal cardiac function;
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- Suffering from other malignant tumors at the same time; except for the following cases: ①Have received treatment for the purpose of cure, and have no known active malignance for ≥5 years before enrollment; ② Adequately treated non-melanoma skin cancer or malignant lentigo with no signs of disease (even if less than 3 years before randomization); ③ Adequately treated carcinoma in situ with no signs of disease (even if less than 3 years before randomization);
- AIDS patients, syphilis patients, active type Hepatitis B (HBV-DNA detectable) patients, and Hepatitis C patients;
- Any concurrent medical condition or disease (such as active systemic infection) that may interfere with study procedures or results, or which, in the judgment of the investigator, poses a risk to participation in this study；
- Inability to understand or comply with the research protocol;
- Received major surgery within 4 weeks before randomization;
- Participate in other clinical investigators at the same time one month before enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
Wenjie Liu
About this study
Official title: Comparing the Efficacy and Safety of Venetoclax Combined With Decitabine/Azacitidine and Aclarubicin Versus Venetoclax Combined With Decitabine/Azacitidine in Treatment-Naive Elderly Patients With Acute Myeloid Leukemia
This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Decitabine/Azacitidine and Aclarubicin) versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia.
This study involves the following:
Venetoclax, Decitabine/Azacitidine, Aclarubicin (investigational combination) Venetoclax and Decitabine/Azacitidine (per standard of care)
Read the detailed description
This is an open-label, multicenter, phase Ⅲ randomized clinical trial to compare the therapeutic efficacy and safety of Venetoclax combined with Decitabine/Azacitidine and Aclarubicin versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia (AML).
The FDA has approved the combination therapy of Venetoclax and Decitabine/Azacitidine for elderly (> 60-year-old) patients with newly diagnosed AML not eligible for intensive chemotherapy. Venetoclax is an inhibitor of BCL-2 (B-cell lymphoma 2, a protein that initiates tumor growth, disease progression, and drug resistance), which can lead to cancer cell death.
Aclarubicin (Acla) is an anthracycline antitumor drug and is a type II topoisomerase Inhibitor that prevents topoisomerase II from binding to DNA primarily by intercalating into DNA strands, resulting in chromatin damage injury without causing DNA damage. In addition to causing chromatin damage, Acla also results in epigenetic inheritance Changes in gene transmission, DNA damage response signals, and apoptosis. Furthermore, in the cytoplasm, Acla can also exert cytotoxic effects by affecting mitochondrial respiratory function. Therefore, Acla is a highly efficient and broad-spectrum chemotherapeutic drug, which is widely used in the treatment of various hematological tumors and solid tumors. In treatment-naive elderly patients with AML, the DCAG (Decitabine-Cytarabine-Aclarubicin-GCSF) regimen can improve the prognosis according to our previous research results. Acla also has relatively mild side effects in the treatment of AML patients.
Participants will be randomly assigned to one of the different treatment groups and followed with consolidated therapy with the same regimen of 2-4 cycles. After completion of study treatment, participants are followed up every 3 months for up to 2 years.
It is expected that about 170 people will take part in this research study.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Venetoclax-Decitabine/Azacitidine-Aclarubicin Association, Venetoclax-Decitabine/Azacitidine Association
- 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.
Venetoclax-Decitabine/Azacitidine-Aclarubicin AssociationDrug
Treatment with Venetoclax+Decitabine/Azacitidine+Aclarubicin
Venetoclax-Decitabine/Azacitidine AssociationDrug
Treatment with Venetoclax+Decitabine/Azacitidine
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax combined with Decitabine/Azacitidine and Aclarubicin | Experimental | Venetoclax (Ven): oral once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
Decitabine (DAC): 20mg/m2 intravenous for 1 hour daily (d1 to d5);
Azacitidine (AZA): 75mg/m2 subcutaneous at two different sites daily (d1 to d7);(Choose decitabine or azacitidine according to the patient's wishes)
Aclarubicin (Acla): 10mg/m2 intravenous daily (d1 to d3); Receives: Drug: Venetoclax-Decitabine/Azacitidine-Aclarubicin Association |
| Venetoclax combined with Decitabine/Azacitidine | Active comparator | Venetoclax (Ven): oral once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
Decitabine (DAC): 20mg/m2 intravenous for 1 hour daily (d1 to d5);
Azacitidine (AZA): 75mg/m2 subcutaneous at two different sites daily (d1 to d7);(Choose decitabine or azacitidine according to the patient's wishes) Receives: Drug: Venetoclax-Decitabine/Azacitidine Association |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with complete remission (CR) and complete remission with incomplete marrow recovery (CRi)
CR is defined as absolute neutrophil count > 10^9/ L, platelets > 100×10^9/L, red cell transfusion independence, and bone marrow with < 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of < 10^9/L or platelets < 100×10^9/L.
Measured: From randomization to the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (7)
Partial Remission (PR) Rate
PR is defined as bone marrow with 5%~25% blasts, at least 50% lower than the initial diagnosis.
Measured: From randomization to the end of Cycle 1 (each cycle is 28 days)
Overall Response Rate (ORR)
Complete Remission/ Complete Remission with incomplete count recovery/ Partial Remission/ Morphologic Leukemia Free State
Measured: From randomization to the end of Cycle 1 (each cycle is 28 days)
Rate of Minimal Residual Disease (MRD) negativity
Percentage of participants who converted to MRD < 10^-3 before initiation of consolidation therapy. MRD is measured by MFC and RT-qPCR.
Measured: From randomization to the end of Cycle 1 (each cycle is 28 days)
Overall survival (OS)
It is measured from the date of randomization to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Measured: From the time of randomization to time for up to 2 years
Disease-Free Survival (DFS)
It is defined as the time from the date of CR/CRi to the date of recurrence or death.
Measured: From the time of randomization to time for up to 2 years
Early Mortality Rate
Measured: From the time of randomization to time for up to 2 years
Cumulative incidence of relapse (CIR)
It is measured from the date of CR/CRi to the date of relapse.
Measured: From the time of CR/CRi to time for up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Mar 2021
- Primary completion28 Jun 2023 (estimated)
- Study completion28 Feb 2025 (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 The First Affiliated Hospital with Nanjing Medical 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Jiangning Hospital of Nanjing Medical University, Huai'an First People's Hospital, Yancheng First People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264883
- Sponsor's protocol ID
- 2021-SR-278
- Status last verified
- May 2023
- First submitted
- 27 Feb 2022
- Last updated
- 30 May 2023
- Results posted
- 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 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Safety of Venetoclax Combined With Decitabine/Azacitidine and Aclarubicin Versus Venetoclax Combined With Decitabine/Azacitidine in Treatment-Naive Elderly Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05264883
- Acronym / sponsor ID
- 2021-SR-278
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Jiangning Hospital of Nanjing Medical University, Huai'an First People's Hospital, Yancheng First People's Hospital
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Jun 2023 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 3 Mar 2022 (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.
This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Decitabine/Azacitidine and Aclarubicin) versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia.
This study involves the following:
Venetoclax, Decitabine/Azacitidine, Aclarubicin (investigational combination) Venetoclax and Decitabine/Azacitidine (per standard of care)
Detailed description
This is an open-label, multicenter, phase Ⅲ randomized clinical trial to compare the therapeutic efficacy and safety of Venetoclax combined with Decitabine/Azacitidine and Aclarubicin versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia (AML).
The FDA has approved the combination therapy of Venetoclax and Decitabine/Azacitidine for elderly (> 60-year-old) patients with newly diagnosed AML not eligible for intensive chemotherapy. Venetoclax is an inhibitor of BCL-2 (B-cell lymphoma 2, a protein that initiates tumor growth, disease progression, and drug resistance), which can lead to cancer cell death.
Aclarubicin (Acla) is an anthracycline antitumor drug and is a type II topoisomerase Inhibitor that prevents topoisomerase II from binding to DNA primarily by intercalating into DNA strands, resulting in chromatin damage injury without causing DNA damage. In addition to causing chromatin damage, Acla also results in epigenetic inheritance Changes in gene transmission, DNA damage response signals, and apoptosis. Furthermore, in the cytoplasm, Acla can also exert cytotoxic effects by affecting mitochondrial respiratory function. Therefore, Acla is a highly efficient and broad-spectrum chemotherapeutic drug, which is widely used in the treatment of various hematological tumors and solid tumors. In treatment-naive elderly patients with AML, the DCAG (Decitabine-Cytarabine-Aclarubicin-GCSF) regimen can improve the prognosis according to our previous research results. Acla also has relatively mild side effects in the treatment of AML patients.
Participants will be randomly assigned to one of the different treatment groups and followed with consolidated therapy with the same regimen of 2-4 cycles. After completion of study treatment, participants are followed up every 3 months for up to 2 years.
It is expected that about 170 people will take part in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venetoclax combined with Decitabine/Azacitidine and Aclarubicin | Experimental | Drug: Venetoclax-Decitabine/Azacitidine-Aclarubicin AssociationVenetoclax (Ven): oral once daily (100 mg d1, 200 mg d2, 400 mg d3-28); Decitabine (DAC): 20mg/m2 intravenous for 1 hour daily (d1 to d5); Azacitidine (AZA): 75mg/m2 subcutaneous at two different sites daily (d1 to d7);(Choose decitabine or azacitidine according to the patient's wishes) Aclarubicin (Acla): 10mg/m2 intravenous daily (d1 to d3); |
| Venetoclax combined with Decitabine/Azacitidine | Active comparator | Drug: Venetoclax-Decitabine/Azacitidine AssociationVenetoclax (Ven): oral once daily (100 mg d1, 200 mg d2, 400 mg d3-28); Decitabine (DAC): 20mg/m2 intravenous for 1 hour daily (d1 to d5); Azacitidine (AZA): 75mg/m2 subcutaneous at two different sites daily (d1 to d7);(Choose decitabine or azacitidine according to the patient's wishes) |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with acute myeloid leukemia (AML) diagnosed by bone marrow morphology and immunophenotyping (in line with WHO 2016 diagnostic criteria);
- No previous anti-acute leukemia treatment (including demethylating drugs), except hydroxyurea and Leukocyte apheresis;
- Exclude acute promyelocytic leukemia (APL) at the bone marrow morphology or molecular level;
- Age 60-80 years old;
- Aspartate aminotransferase (ALT), alanine aminotransferase (AST), and alkaline phosphatase (ALP)≤ 3×upper limit of normal (ULN), serum bilirubin≤ 1.5×ULN; serum creatinine≤ 2.0×ULN; serum heart rate≤ 2.0×ULN;
Key exclusion criteria (12 listed)
- Acute promyelocytic leukemia, myeloid sarcoma, accelerated phase and blast of chronic myeloid leukemia;
- Patients with relapsed AML;
- Allergy to any drug involved in the program;
- Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
- The liver and kidney functions are obviously abnormal, exceeding the inclusion criteria;
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 |
|---|---|---|
| Venetoclax-Decitabine/Azacitidine-Aclarubicin AssociationTreatment with Venetoclax+Decitabine/Azacitidine+Aclarubicin | Drug | Venetoclax combined with Decitabine/Azacitidine and Aclarubicin |
| Venetoclax-Decitabine/Azacitidine AssociationTreatment with Venetoclax+Decitabine/Azacitidine | Drug | Venetoclax combined with Decitabine/Azacitidine |
Primary outcome
Percentage of participants with complete remission (CR) and complete remission with incomplete marrow recovery (CRi)
Time frame: From randomization to the end of Cycle 1 (each cycle is 28 days)
CR is defined as absolute neutrophil count > 10^9/ L, platelets > 100×10^9/L, red cell transfusion independence, and bone marrow with < 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of < 10^9/L or platelets < 100×10^9/L.
7 secondary outcomes
Partial Remission (PR) Rate
Time frame: From randomization to the end of Cycle 1 (each cycle is 28 days)
Overall Response Rate (ORR)
Time frame: From randomization to the end of Cycle 1 (each cycle is 28 days)
Rate of Minimal Residual Disease (MRD) negativity
Time frame: From randomization to the end of Cycle 1 (each cycle is 28 days)
Overall survival (OS)
Time frame: From the time of randomization to time for up to 2 years
Disease-Free Survival (DFS)
Time frame: From the time of randomization to time for up to 2 years
Early Mortality Rate
Time frame: From the time of randomization to time for up to 2 years
Cumulative incidence of relapse (CIR)
Time frame: From the time of CR/CRi to time for up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Venetoclax-Decitabine/Azacitidine-Aclarubicin Association and Venetoclax-Decitabine/Azacitidine Association in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital with Nanjing 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 8 inclusion and 12 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 30 May 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Wenjie Liu, M.D (+8615895891160, dreaming88516@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with complete remission (CR) and complete remission with incomplete marrow recovery (CRi) (time frame: From randomization to the end of Cycle 1 (each cycle is 28 days)). 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 30 May 2023.