Acute Myeloid LeukemiaPhase 2NCT05361057
Efficacy of Venetoclax Based Regimen in Prevention Relapse of Consecutive MRD Positive AML Patients
A Phase 2 study testing Venetoclax, Azacitidine and Venetoclax, daunorubicin, cytarabine in people with Acute Myeloid Leukemia and Measurable Disease, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Measurable disease (MRD) plays an important role in the therapeutic efficacy and prognosis of acute myeloid leukemia (AML). Studies show that persistent MRD positivity after induction indicates that the patient has a higher risk of recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Measurable Disease
- What is being tested?
- Venetoclax, Azacitidine and Venetoclax, daunorubicin, cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2022to 23 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed acute myeloid leukemia
- Received chemotherapy within 24 months and has completed the consolidation treatment plan
- In complete remission
- With MRD positive: abnormal myeloid cells in bone marrow ≥ 0.1%, or NPM1 gene mutation and other fusion gene positive(RUNX 1-RUNX1T 1、CBFB-MYH11 and DEK-NUP214), the PCR quantification ≥1%.
- Age≥ 18 years #male or female
- ECOG-PS score 0-2
- Aboratory tests#within 7 days before chemotherapy# 1). Serum total bilirubin≤1.5xULN# 2). Serum AST and ALT≤2.5xULN 3). Serum creatinine≤2xULN# 4). Cardiac enzymes≤2xULN 5). Ejection fraction >50% by ECHO#
- Written informed consent
Who cannot join
- Hematological relapse (the proportion of blast cells in bone marrow is greater than 5%)
- Receive hematopoietic stem cell transplantation within 4 weeks
- APL
- Have been treated with venetoclax in the past 6 months (who can be enrolled after stopping for more than 6 months)
- Suffering from malignant tumors of other organs (those requiring treatment)
- Pregnant or lactating women
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- Active heart diseases
- Severe active infection
- Unfit for enrollment evaluated by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Arm, Multicenter Clinical Study to Evaluate the Efficacy of Venetoclax Combined With Azacytidine or DA Regimen in Prevention the Relapse of Consecutive MRD Positive AML Patients
Measurable disease (MRD) plays an important role in the therapeutic efficacy and prognosis of acute myeloid leukemia (AML). Studies show that persistent MRD positivity after induction indicates that the patient has a higher risk of recurrence. Even if the patient is assessed as a low risk group, once there is persistent MRD positive, Allogeneic hematopoietic stem cell transplantation (allo HSCT) or clinical trials should be considered to improve the overall survival of patients. However, some patients cannot accept allo HSCT due to economic reasons or lack of suitable donors. How to prolong the recurrence free survival of these patients is still a great challenge. Platzbecker et al. applied azacytidine (AZA) monotherapy to AML patients with continuous MRD positive after combined chemotherapy. The results showed that the preemptive treatment of AZA could prevent or significantly delay the hematological relapse of MDS or AML patients with MRD positive. In addition, the application of venetoclax has significantly changed the therapeutic prospect of AML and provided new opportunities. Studies have shown that venetoclax can enhance the activity of anti HMA, cytarabine, idarubicin and other drugs. The curative effect of venetoclax combined with AZA in the treatment of elderly AML patients who are not suitable for intensive treatment is better than that of single AZA regimen, and the negative rate of MRD after induction treatment of venetoclax combined with HMA is higher (54-81%). Therefore, the investigators believe that for patients who continue to be MRD positive after induction and consolidation treatment, venetoclax based regimen may be an effective preemptive treatment regimen, which can prolong the relapse free time and overall survival of these patients
Read the detailed description
In the study, 40 patients will be enrolled and treated with venotoclax combined AZA and DA regimen. Patients receive major response will be given venotoclax combined AZA regimen as maintenance treatment. The primary endpoint was 6 month relapse-free survival. Measurable residual disease (MRD) will be detected at the beginning of the therapy and after the therapy. The adverse effect will also be explored.
Preemptive chemotherapy: regimen 1: azacytidine 75 mg/m2 d1-7，venetoclax: 100mg d1, 200mg d2, 400mg d3-21; regimen 2: daunorubicin：45mg/m2 d1-2, cytarabine:100mg/ m2 d1-5, venetoclax: 100mg d1, 200mg d2, 400mg d3-14; maintenance therapy: patient in regimen 1 group: azacytidine 75 mg/m2 d1-7，venetoclax: 400mg d1-14, for 4 cycles, patients in regimen 2 group: azacytidine 75 mg/m2 d1-7，venetoclax: 400mg d1-14, for 4 cycles.
- Conditions
- Acute Myeloid Leukemia, Measurable Disease
- Being tested
- Venetoclax, Azacitidine, Venetoclax, daunorubicin, cytarabine
- 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, AzacitidineDrug
The patients were administrated with azacytidine 75 mg/m2 d1-7，venetoclax: 100mg d1, 200mg d2, 400mg d3-21;
Venetoclax, daunorubicin, cytarabineDrug
The patients were administrated with daunorubicin：45mg/m2 d1-2, cytarabine:100mg/ m2 d1-5, venetoclax: 100mg d1, 200mg d2, 400mg d3-14
| Study group | Role | What they receive |
|---|---|---|
| venetoclax pluse azacitidine arm | Experimental | azacytidine 75 mg/m2 d1-7，venetoclax: 100mg d1, 200mg d2, 400mg d3-21 Receives: Drug: Venetoclax, Azacitidine |
| venetoclax pluse DA arm | Active comparator | daunorubicin：45mg/m2 d1-2, cytarabine:100mg/ m2 d1-5, venetoclax: 100mg d1, 200mg d2, 400mg d3-14 Receives: Drug: Venetoclax, daunorubicin, cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse free survival
survival from the preemptive therapy to relapse
Measured: 6 months
Secondary outcomes (3)
major response
The MRD level turns negative or the specific value decreases by 1 order of magnitude
Measured: 3 months
overall survival
duration from enrollment to death or loss of followup
Measured: 1 year
relapse free survival
survival from the preemptive therapy to relapse
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start29 Jun 2022
- Primary completion28 Feb 2023
- Study completion23 Jan 2024
Why it stopped: The research center has conducted a more comprehensive study.
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 Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361057
- Sponsor's protocol ID
- IIT2022006
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 5 Dec 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 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Multicenter Clinical Study to Evaluate the Efficacy of Venetoclax Combined With Azacytidine or DA Regimen in Prevention the Relapse of Consecutive MRD Positive AML Patients
- ClinicalTrials.gov ID
- NCT05361057
- Acronym / sponsor ID
- IIT2022006
- Conditions
- Acute Myeloid Leukemia, Measurable Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The research center has conducted a more comprehensive study.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 4 May 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.
Measurable disease (MRD) plays an important role in the therapeutic efficacy and prognosis of acute myeloid leukemia (AML). Studies show that persistent MRD positivity after induction indicates that the patient has a higher risk of recurrence. Even if the patient is assessed as a low risk group, once there is persistent MRD positive, Allogeneic hematopoietic stem cell transplantation (allo HSCT) or clinical trials should be considered to improve the overall survival of patients. However, some patients cannot accept allo HSCT due to economic reasons or lack of suitable donors. How to prolong the recurrence free survival of these patients is still a great challenge. Platzbecker et al. applied azacytidine (AZA) monotherapy to AML patients with continuous MRD positive after combined chemotherapy. The results showed that the preemptive treatment of AZA could prevent or significantly delay the hematological relapse of MDS or AML patients with MRD positive. In addition, the application of venetoclax has significantly changed the therapeutic prospect of AML and provided new opportunities. Studies have shown that venetoclax can enhance the activity of anti HMA, cytarabine, idarubicin and other drugs. The curative effect of venetoclax combined with AZA in the treatment of elderly AML patients who are not suitable for intensive treatment is better than that of single AZA regimen, and the negative rate of MRD after induction treatment of venetoclax combined with HMA is higher (54-81%). Therefore, the investigators believe that for patients who continue to be MRD positive after induction and consolidation treatment, venetoclax based regimen may be an effective preemptive treatment regimen, which can prolong the relapse free time and overall survival of these patients
Detailed description
In the study, 40 patients will be enrolled and treated with venotoclax combined AZA and DA regimen. Patients receive major response will be given venotoclax combined AZA regimen as maintenance treatment. The primary endpoint was 6 month relapse-free survival. Measurable residual disease (MRD) will be detected at the beginning of the therapy and after the therapy. The adverse effect will also be explored.
Preemptive chemotherapy: regimen 1: azacytidine 75 mg/m2 d1-7，venetoclax: 100mg d1, 200mg d2, 400mg d3-21; regimen 2: daunorubicin：45mg/m2 d1-2, cytarabine:100mg/ m2 d1-5, venetoclax: 100mg d1, 200mg d2, 400mg d3-14; maintenance therapy: patient in regimen 1 group: azacytidine 75 mg/m2 d1-7，venetoclax: 400mg d1-14, for 4 cycles, patients in regimen 2 group: azacytidine 75 mg/m2 d1-7，venetoclax: 400mg d1-14, for 4 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| venetoclax pluse azacitidine arm | Experimental | Drug: Venetoclax, Azacitidineazacytidine 75 mg/m2 d1-7，venetoclax: 100mg d1, 200mg d2, 400mg d3-21 |
| venetoclax pluse DA arm | Active comparator | Drug: Venetoclax, daunorubicin, cytarabinedaunorubicin：45mg/m2 d1-2, cytarabine:100mg/ m2 d1-5, venetoclax: 100mg d1, 200mg d2, 400mg d3-14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed acute myeloid leukemia
- Received chemotherapy within 24 months and has completed the consolidation treatment plan
- In complete remission
- With MRD positive: abnormal myeloid cells in bone marrow ≥ 0.1%, or NPM1 gene mutation and other fusion gene positive(RUNX 1-RUNX1T 1、CBFB-MYH11 and DEK-NUP214), the PCR quantification ≥1%.
- Age≥ 18 years #male or female
Key exclusion criteria (9 listed)
- Hematological relapse (the proportion of blast cells in bone marrow is greater than 5%)
- Receive hematopoietic stem cell transplantation within 4 weeks
- APL
- Have been treated with venetoclax in the past 6 months (who can be enrolled after stopping for more than 6 months)
- Suffering from malignant tumors of other organs (those requiring treatment)
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, AzacitidineThe patients were administrated with azacytidine 75 mg/m2 d1-7，venetoclax: 100mg d1, 200mg d2, 400mg d3-21; | Drug | venetoclax pluse azacitidine arm |
| Venetoclax, daunorubicin, cytarabineThe patients were administrated with daunorubicin：45mg/m2 d1-2, cytarabine:100mg/ m2 d1-5, venetoclax: 100mg d1, 200mg d2, 400mg d3-14 | Drug | venetoclax pluse DA arm |
Primary outcome
relapse free survival
Time frame: 6 months
survival from the preemptive therapy to relapse
3 secondary outcomes
major response
Time frame: 3 months
overall survival
Time frame: 1 year
relapse free survival
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The research center has conducted a more comprehensive study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Venetoclax, Azacitidine and Venetoclax, daunorubicin, cytarabine in people with Acute Myeloid Leukemia and Measurable Disease, run by Institute of Hematology & Blood Diseases Hospital, China 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 9 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: stopped early, as of the sponsor's last update on 5 Dec 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.
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?
The study was stopped early (reason given: The research center has conducted a more comprehensive study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse free survival (time frame: 6 months). 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 Dec 2025.