Acute Myeloid Leukemia, Myelodysplastic Syndromes
Conditions
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
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.
Interventions
DRUGidarubicin
Idarubicin 6mg/m2 d5-7
DRUGCytarabine
Cytarabine 60mg/m2 d5-9
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. aged 18-60 years 2. 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. 3. Eastern Cooperative Oncology Group performance status of 0-2. 4. adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography.
Exclusion criteria
1. younger than 18 years old, or older than 60 years old. 2. Diagnosed as acute promyelocytic leukaemia. 3. Pretreated with anthracycline. 4. CNS involvement. 5. Positive for HIV, hepatitis B virus, or hepatitis C virus. 6. 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 7. Uncontrollable systemic infection (viral, bacterial, or fungal), 8. Inability to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CR | Week 6 | assessment of the composite complete remission rate (CR=CR+CRi) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactWeiyan Zheng, MD
Backup ContactXuepin Luo, MD
Outcome results
None listed