AML (Acute Myelogenous Leukemia)Phase 2DAV-AML-2024NCT06635681
Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML
A Phase 2 study testing Daunorubicin, Cytarabine and Venetoclax in people with AML (Acute Myelogenous Leukemia), run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients. Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- AML (Acute Myelogenous Leukemia)
- What is being tested?
- Daunorubicin, Cytarabine and Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2024to 1 Oct 2028
- Phase
- Phase 2
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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards.
- Age ≥14 years old, ≤ 60 years old, male or female.
- The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
- Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :
- Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);
- AST and ALT≤ 2.5 times the upper limit of normal value (same age);
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- Blood creatinine < 2 times the upper limit of normal (same age);
- Myocardial enzymes < 2 times the upper limit of normal (same age);
- Left ventricular ejection fraction \>50% by measure of echocardiogram (ECHO). Informed consent must be signed before the commencement of all specific study procedures, and signed by the patient himself or his immediate family. Considering the patient\'s condition, if the patient\'s signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient\'s immediate family.
Who cannot join
- Subjects who meet any of the following criteria are excluded from the study:
- Acute promyelocytic leukemia with PML-RARA fusion gene
- Acute myeloid leukemia with BCR-ABL fusion gene
- Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden).
- Concurrent malignant tumors of other organs (those requiring treatment).
- Active heart disease, defined as one or more of the following:
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- A history of uncontrolled or symptomatic angina;
- Myocardial infarction less than 6 months after enrollment;
- Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;
- Uncontrolled or symptomatic congestive heart failure (> NYHA level 2);
- Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).
- Those who were not considered suitable for inclusion by the researchers.
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
Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
hui wei, MD, 86-13132507161, weihui@ihcams.ac.cn
About this study
Official title: Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of Acute Myeloid Leukemia : a Multi-center, Single-arm Clinical Trial
Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients.
Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival.
Read more
Since AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy.
Therefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.
Read the detailed description
Patients will receive 1 course of intensive chemotherapy combined with venetoclax for induction and those who achieved complete remission will receive 3 courses of intermediate-dose cytarabine combined with Venetoclax for consolidation. After consolidation therapy, Venetoclax in combination with azacitidine will be applied for 6 courses as maintenance treatment. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk groups and intermediate-risk with positive measurable residual disease.
- Conditions
- AML (Acute Myelogenous Leukemia)
- Being tested
- Daunorubicin, Cytarabine, Venetoclax, Azacitidine
- 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.
DaunorubicinDrug
60mg/m2/d d1-3 in Induction therapy
CytarabineDrug
Cytarabine 100mg/m2/d d1-7 in Induction therapy, 2g/m2 q12h d1-3 in Consolidation therapy
VenetoclaxDrug
100mg d-2, 200mg d-1, 400mg d1-7 in Induction therapy, 400mg d1-7 in Consolidation therapy and Maintenance treatment
AzacitidineDrug
75mg/m2/d d1-5
| Study group | Role | What they receive |
|---|---|---|
| venetoclax combined with intensive chemotherapy | Experimental | Induction therapy: daunorubicin, cytarabine, combined with venetoclax for 1 course.
Consolidation therapy: cytarabine combined with venetoclax for 3 courses.
Maintenance therapy: azacitidine combined with venetoclax for 6 courses. Receives: Drug: Daunorubicin; Drug: Cytarabine; Drug: Venetoclax; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
All patients definitions for the trial; From the date of enrollment to the time of treatment failure after two courses of induction therapy, recurrence after CRc, date of all-cause death, or the date of last survival follow-up.
Measured: up to 2 years after the date of the last enrolled participants
Secondary outcomes (7)
Complete remission (CR)/CR with partial hematologic recovery (CRh)/CR with incomplete hematologic recovery (CRi) with negative MRD detected by flow cytometry
The ratio of CR/CRh/CRi with negative MRD detected by flow cytometry after induction, consolidation, and maintenance therapy.
Measured: up to 1 years after the date of the last enrolled participants
CR/CRh/CRi with negative MRD detected by PCR
The ratio of CR/CRh/CRi with negative MRD detected by PCR after induction, consolidation, and maintenance therapy.
Measured: up to 1 years after the date of the last enrolled participants
overall survival (OS)
Used to evaluate all patients who enter clinical trials. From the date of entry into the trial until the date of patient death (including any cause) or last survival follow-up.
Measured: up to 2 years after the date of the last enrolled participants
30-day mortality
Percentage of patients who died within 30 days from enrollment.
Measured: within 30 days of the date of the last enrolled participants
60-day mortality
Percentage of patients who died within 60 days from enrollment.
Measured: within 60 days of the date of the last enrolled participants
Complete remission (CR)/CR with partial hematologic recovery (CRh)/CR with incomplete hematologic recovery (CRi) rate
The ratio of patients achieved CR/CRh/CRi after two courses of induction therapy.
Measured: up to 3 months after the date of the last enrolled participants
Relapse-free survival (RFS)
Defined only for patients achieving CRc; measured from the date of achievement of remission until the date of hematologic relapse or death from any cause; patients not known to have relapsed or died at last follow-up are censored on the date they were last known to be alive
Measured: up to 2 years after the date of the last enrolled participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start29 Sep 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myelogenous Leukemia)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Wei, MD, Principal investigator, Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635681
- Sponsor's protocol ID
- IIT2024074
- Acronym
- DAV-AML-2024
- Status last verified
- May 2026
- First submitted
- 27 Sep 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No