The purpose of this study is to evaluate of the clinical efficacy and safety of DLAAG protocol in the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome with blast excess
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Decitabine,iv,0.1-0.2mg/kg, Day1-Day3 per week,up to 3 weeks
cytarabine, iv,15mg/m2 q12h, Day1-Day10
All-transretinoic acid, 45mg/d Day4-Day6;15mg/d Day7-Day20
Beijing Friendship Hospital
Beijing, China
NOT_YET_RECRUITINGFujian Medical University Union Hospital
Fuzhou, China
NOT_YET_RECRUITINGThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
Complete Response Rate (CR)
Morphologic CR - patient independent of transfusions * Absolute neutrophil count(ANC) \>1000/ Microliter(mcL) * Platelets ≥100,000/mcL * No residual evidence of extramedullary disease Cytogenetic CR - cytogenetics normal (in those with previously abnormal cytogenetics) Molecular CR - molecular studies negative CR with incomplete blood cells count recovery(CRi) - There are some clinical trials, particularly those that focus on the elderly or those with antecedent myelodysplasia, that include a variant of complete response referred to as CRi. This has been defined as \<5% marrow blasts, either ANC \<1000/mcL or platelets \<100,000/mcL, and transfusion independence but with persistence of cytopenia (usually thrombocytopenia).
Time frame: at the end of every course(about 4 weeks)
Early death rate
The rate of early death within 30 days
Time frame: the death rate after treating Day1 to Day30
Leukemia free survival (LFS)
Morphologic leukemia-free state Bone marrow \<5% blasts in an aspirate with spicules No blasts with Auer rods or persistence of extramedullary disease
Time frame: from enrolling to the end of 2-year following up
Overall survival(OS)
The time from the date of enrolling to the date of death due to any reasons or the last following date
Time frame: from enrolling to the end of 2-year following up
The rate of adverse reaction the rate of adverse reaction
the rate of adverse reaction, according to Standard for World Health Organization(WHO) acute and subacute toxicity
Time frame: from enrolling to the end of 2-year following up
Duration of hospitalization
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G-CSF 300ug,sc,Day 0 until CR is achieved
Shanghai Tong Ren hospital
Shanghai, China
RECRUITINGThe center hospital of Shanghai Fengxian District
Shanghai, China
NOT_YET_RECRUITINGFirst Affiliated Hospital of Zhengzhou University.
Zhengzhou, China
NOT_YET_RECRUITINGThe time from the date of be hospitalized to the date of be discharged
Time frame: from enrolling to the end of 2-year following up
The rate of relapse
Relapse following complete response is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the bone marrow, not attributable to another cause (eg, bone marrow regeneration after consolidation therapy) or extramedullary relapse
Time frame: from enrolling to the end of 2-year following up