acute myelogenous leukemia
Conditions
Interventions
Group 1:1. Consolidation therapy with DA regimen: Intravenous injection daunorubicin (45mg/m2/day) from day 1 through day 3, combined with 1.5g/m2 of cytarabine twice a day with over 3-hours infusion
Group 1 (to be continued):2. Consolidation therapy with HA regimen: Intravenous injection Homoharringtonine (4mg/m2/day) from day 1 through day 5, combined with 1.5g/m2 of cytarabine twice a day with
Group 1 (to be continued):3. Consolidation therapy with EA regimen: Intravenous injection Etoposide (100mg/m2/day) from day 1 through day 5, combined with 1.5g/m2 of cytarabine twice a day with over 3
Group 1 (to be continued):4. Consolidation therapy with MA regimen: Intravenous injection Mitoxanetrone (7mg/m2/day) from day 1 through day 3, combined with 1.5g/m2 of cytarabine twice a day with over
Group 1 (to be continued):5. Consolidation therapy with TA regimen: Intravenous injection Topotecan (1.25mg/m2/day) from day 1 through day 5, combined with 1.5g/m2 of cytarabine twice a day with over
Group 1 (to be continued):6. Consolidation therapy with AA regimen: Intravenous injection Aclarubicin (20mg/m2/day) from day 1 through day 5, combined with 1.5g/m2 of cytarabine twice a day with over
Group 1 (to be continued):7. Prophylaxis of central nervous system leukemia (CNS-L): intrathecal injection with 5mg dexamethasone plus 15mg MTX for 6 times totally after achievement of CR.
Group 2:1. Consolidation therapy with DA regimen: Intravenous injection daunorubicin (45mg/m2/day) from day 1 through day 3, combined with 2.0g/m2 of cytarabine twice a day with over 3-hours infusion
Group 2 (to be continued):2. Consolidation therapy with HA regimen: Intravenous injection Homoharringtonine (4mg/m2/day) from day 1 through day 5, combined with 2.0g/m2 of cytarabine twice
Sponsors
Department of Hematology, the Second Affiliated Hospital of Dalian Medical University.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: The enrolled acute myelogenous leukemia (AML) patients should fulfill all the following requirements: 1. Newly diagnosed AML aged 15 to 55 years; 2. Primary AML except for APL and MDS-transformed AML. According to WHO diagnosis criteria, leukemia blasts should account for more than 20% in bone marrow or peripheral blood, and immunophenotyping of leukemia blasts indicating a compatibility with the diagnosis of AML; 3. AML patients have achieved morphological complete remission after 1 to 2 courses of induction therapy; 4. ECOG score is 0, 1 or 2 before a patient is enrolled; 5. The expected survival should be more than 3 months; 6. Without severe complications such as renal insufficiency or cardiac insufficiency; 7. With no more than 3- to 5- fold upper limit of normal range for GPT, GGT, or bilirubin, and no more than 2-fold upper limit of normal range for blood creatinine and myocardial enzymes at 2 weeks before recruitment of patients; 8. Hepatitis B virus DNA copies lower than 100,000 copies/mL; 9. A female patient should be not pregnant, and she should consent to use appropriate contraceptive methods during treatment and follow-up for the next 1 year; 10. Necessary to understand the treatment regimens of this clinical trial, and sign an informed consent before treatment.
Exclusion criteria
Exclusion criteria: AML patients should be excluded with any of the following items: 1. Undergoing any chemotherapy regimen; 2. Experienced a major surgery except for surgical operations for diagnosis during past 4 weeks; 3. Complication of central nervous system leukemia (CNS-L); 4. Active hepatitis B infection, or positive antibody against hepatitis C virus; 5. Severe diseases which may constrain the enrollment, including a progressive infection, out-of-control diabetes, severe cardiac dysfunction or angina pectoris, hepatic or renal insufficiency; 6. Undergoing other clinical trials, or administration of therapeutic regimens of other clinical trials during past 3 months; 7. Female APL patients during pregnant or lactation period, or without appropriate contraceptive methods; 8. Disapproval of this clinical trial by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival (3-year OS);3-year disease-free survival (3-year DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year event-free survival (3-year EFS);Relapse rate;Time to pregression of disease; | — |
Countries
China
Contacts
Public ContactJin-Song Yan
Outcome results
None listed