Acute Myeloid LeukemiaPhase 2NCT06050941
Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults AML and MDS
A Phase 2 study testing idarubicin and Cytarabine in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by First Affiliated Hospital of Zhejiang University.
Trial summary
Reduced intensive 3 + 5 idarubicin and cytarabine chemotherapy plus venetoclax as first-line treatment for adults with acute myeloid leukaemia and high-risk myelodysplastic syndrome Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- idarubicin and Cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2024to 2 Apr 2027
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-60 years
- had a confirmed diagnosis of previously untreated de novo acute myeloid leukaemia or high risk myelodysplastic syndrome by bone marrow examination according to the criteria presented by WHO.
- Eastern Cooperative Oncology Group performance status of 0-2.
- adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography.
Who cannot join
- younger than 18 years old, or older than 60 years old.
- Diagnosed as acute promyelocytic leukaemia.
- Pretreated with anthracycline.
- CNS involvement.
- Positive for HIV, hepatitis B virus, or hepatitis C virus.
- New York Heart Association cardiovascular disability status higher than grade 2 (grade 2 is defined as cardiac disorder that is asymptomatic at rest, but ordinary physical activity might result in fatigue, palpitations, dyspnoea, or angina), chronic respiratory diseases requiring continuous supplementary oxygen, inability to take oral medication or malabsorption syndrome
- Uncontrollable systemic infection (viral, bacterial, or fungal),
- Inability to sign the informed consent form.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-center Prospective Single Arm Clinical Study of Reduced Intensive 3 + 5 Idarubicin and Cytarabine Chemotherapy Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndrome
Reduced intensive 3 + 5 idarubicin and cytarabine chemotherapy plus venetoclax as first-line treatment for adults with acute myeloid leukaemia and high-risk myelodysplastic syndrome
Read the detailed description
Multiple clinical trials about chemotherapy plus venetoclax in primary diagnosed AML or relapsed/refractly AML were ongoing to attempt the facility of the combination. Zu et al demostrated that full dose of 3 + 7 daunorubicin and cytarabine chemotherapy plus 8 days escalated venetoclax acheived 91% of CR/CRi with 97% 1-year overall survival and 72% 1-year event-free survival. In this trial , we try to reduced the intensive of 3 + 5 idarubicin and cytarabine chemotherapy, but prolong venetoclax to two weeks in the induction therapy in adults AML/MDS. We expect to increase the induced remission rate by extending the dosage of targeted drug venetoclax, and minimize the side effects by reducing the dose of 3 + 7 induction chemotherapy, so as to achieve the goal of high efficiency and low toxicity.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- idarubicin, Cytarabine
- 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.
idarubicinDrug
Also called Idamycin, Demethoxydaunorubicin
Idarubicin 6mg/m2 d5-7
CytarabineDrug
Also called Cytosar, Cytosine arabinoside
Cytarabine 60mg/m2 d5-9
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Reduced intensive of 3 + 5 Idarubicin and Cytarabine plus Venetoclax as induction therapy Receives: Drug: idarubicin; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR
assessment of the composite complete remission rate (CR=CR+CRi)
Measured: Week 6
Secondary outcomes (4)
MRD
assessment of bone marrow measurable residual disease by flow cytometry
Measured: Week 6
EFS
Evaluate the event-free survival
Measured: 2 years
OS
Evaluated the overall survival
Measured: 2 years
adverse events
Monitor of adverse events
Measured: at any time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start2 Apr 2024 (estimated)
- Primary completion2 Apr 2026 (estimated)
- Study completion2 Apr 2027 (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
- 60 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
- NCT06050941
- Sponsor's protocol ID
- 20230413IAVEN
- 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 Reduced Intensive 3 + 5 Idarubicin and Cytarabine Chemotherapy Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT06050941
- Acronym / sponsor ID
- 20230413IAVEN
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (estimated)
- Primary completion
- 2 Apr 2026 (estimated)
- Study completion
- 2 Apr 2027 (estimated)
- First posted
- 22 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.
Reduced intensive 3 + 5 idarubicin and cytarabine chemotherapy plus venetoclax as first-line treatment for adults with acute myeloid leukaemia and high-risk myelodysplastic syndrome
Detailed description
Multiple clinical trials about chemotherapy plus venetoclax in primary diagnosed AML or relapsed/refractly AML were ongoing to attempt the facility of the combination. Zu et al demostrated that full dose of 3 + 7 daunorubicin and cytarabine chemotherapy plus 8 days escalated venetoclax acheived 91% of CR/CRi with 97% 1-year overall survival and 72% 1-year event-free survival. In this trial , we try to reduced the intensive of 3 + 5 idarubicin and cytarabine chemotherapy, but prolong venetoclax to two weeks in the induction therapy in adults AML/MDS. We expect to increase the induced remission rate by extending the dosage of targeted drug venetoclax, and minimize the side effects by reducing the dose of 3 + 7 induction chemotherapy, so as to achieve the goal of high efficiency and low toxicity.
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: idarubicin, Drug: CytarabineReduced intensive of 3 + 5 Idarubicin and Cytarabine plus Venetoclax as induction therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aged 18-60 years
- had a confirmed diagnosis of previously untreated de novo acute myeloid leukaemia or high risk myelodysplastic syndrome by bone marrow examination according to the criteria presented by WHO.
- Eastern Cooperative Oncology Group performance status of 0-2.
- adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography.
Key exclusion criteria (8 listed)
- younger than 18 years old, or older than 60 years old.
- Diagnosed as acute promyelocytic leukaemia.
- Pretreated with anthracycline.
- CNS involvement.
- Positive for HIV, hepatitis B virus, or hepatitis C virus.
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 |
|---|---|---|
| idarubicinAlso: Idamycin, DemethoxydaunorubicinIdarubicin 6mg/m2 d5-7 | Drug | treatment group |
| CytarabineAlso: Cytosar, Cytosine arabinosideCytarabine 60mg/m2 d5-9 | Drug | treatment group |
Primary outcome
CR
Time frame: Week 6
assessment of the composite complete remission rate (CR=CR+CRi)
4 secondary outcomes
MRD
Time frame: Week 6
EFS
Time frame: 2 years
OS
Time frame: 2 years
adverse events
Time frame: at any time
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 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.
Weiyan Zheng, MD principal investigator
Zhejiang University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing idarubicin and Cytarabine in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by First Affiliated Hospital of Zhejiang University.
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 4 inclusion and 8 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: opening soon, 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.
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?
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 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?
CR (time frame: Week 6). 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.