Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and Myelodysplastic Syndrome
Study Details
Study Description
Brief 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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
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
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: treatment group Reduced intensive of 3 + 5 Idarubicin and Cytarabine plus Venetoclax as induction therapy |
Drug: idarubicin
Idarubicin 6mg/m2 d5-7
Other Names:
Drug: Cytarabine
Cytarabine 60mg/m2 d5-9
Other Names:
|
Outcome Measures
Primary Outcome Measures
- CR [Week 6]
assessment of the composite complete remission rate (CR=CR+CRi)
Secondary Outcome Measures
- MRD [Week 6]
assessment of bone marrow measurable residual disease by flow cytometry
- EFS [2 years]
Evaluate the event-free survival
- OS [2 years]
Evaluated the overall survival
- adverse events [at any time]
Monitor of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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aged 18-60 years
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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.
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Eastern Cooperative Oncology Group performance status of 0-2.
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adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography.
Exclusion Criteria:
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younger than 18 years old, or older than 60 years old.
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Diagnosed as acute promyelocytic leukaemia.
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Pretreated with anthracycline.
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CNS involvement.
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Positive for HIV, hepatitis B virus, or hepatitis C virus.
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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
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Uncontrollable systemic infection (viral, bacterial, or fungal),
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Inability to sign the informed consent form.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- First Affiliated Hospital of Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20230413IAVEN