Acute Myeloid Leukemia
Conditions
Interventions
Intermediate-dose Ara-C:Ara-C 1.5g/m2, q12h d1, 3, 5
IDA 12mg/m2/d, d1-3.
Standard dose Ara-C:Ara-C 100mg/m2/d, 24-hr infusion, d1-7
Intermediate-dose Ara-C:Ara-C 1.5g/m2 q12h, d1-3
High-dose Ara-C:Ara-C 3g/m2 q12h, d1-3
Sponsors
Zheng Changcheng
Eligibility
Sex/Gender
All
Age
14 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. For the patients with acute myeloid leukemia confirmed by morphology, immunology and genetics of bone marrow cells, the classification shall refer to the World Health Organization diagnostic standard (WHO) 2016 standard): non APL; AML with multiple morbid hematopoiesis without advanced MDS and or MPN; AML patients with acute myeloproliferative disease with myelofibrosis and myelosarcoma, WHO AML classification does not make another classification. 2. Patients aged 14-55 years old are not limited to men and women. 3. Patients with ECOG-PS as shown by color Doppler echocardiography 45%. 6. The informed consent must be signed before the start of all specific research procedures. The informed consent shall be signed by the patient or his / her immediate family members for those aged 18 and above; the informed consent shall be signed by the legal guardian of children and adolescents under the age of 18. Considering the patient's condition, if the signature of the patient is not conducive to the treatment of the condition, the legal guardian or the patient's immediate family member shall sign the informed consent.
Exclusion criteria
Exclusion criteria: Patients with any of the following exclusion criteria are not eligible for this trial: 1. Retreated patients (refer to those who have received induction chemotherapy in the past, regardless of the efficacy); 2. Patients with secondary hematopathy (mainly those who have a history of advanced MDS and / or MPN); 3. Treatment related AML, patients with other tumors still in active stage or receiving radiotherapy and chemotherapy due to other tumors within 6 months; 4. Patients suffering from other blood system diseases (such as hemophilia, myelofibrosis and other unsuitable candidates considered by researchers; those with previous abnormal hemogram but without bone marrow examination diagnosed as MDS and MPN are allowed to be included); 5. Acute myeloproliferative disease with myelofibrosis and myelosarcoma in the subtype of AML not classified separately by the World Health Organization AML classification; 6. AML with bcr-abl mutation is not allowed to enter the group because it needs tyrosine kinase inhibitor; 7. HIV positive patients; 8. Pregnant or lactating women; 9. Mental illness that may prevent the subject from completing the treatment or the subject's informed consent; 10. Patients who have participated in clinical trials of other new drugs within 4 weeks; 11. Poor compliance and other situations that the researchers think are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival, EFS;RFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission;overall survival, OS;Disease-free survival, DFS;Peripheral blood recovery time;the time of transfusion;the early mortality;average hospitalization time;RFS;OS;Cumulative recurrence rate;therapy related mortality;adverse reaction; | — |
Countries
China
Contacts
Public ContactZheng Changcheng
Department of Hematology, the First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed