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All patients receive 1-2 cycles of induction chemotherapy,that is DLAAG,which is expected to be 6 weeks/cycle,including decitabine,cytarabine, all-transretinoic acid,and Granulocyte Colony-Stimulating Factor(G-CSF).

patients with CR after the first course of induction therapy (DLAAG) will continue to receive 1 cycle of consolidation therapy, while those with therapy failure will continue the second course of induction therapy. If CR is not achieved, quit the study.

Patients who achieve CR after induction therapy will be in accordance with the guidelines, such as the proposed active treatment of allogeneic hematopoietic stem cell transplantation

Decitabine,iv,0.1-0.2mg/kg, Day1-Day3 per week,up to 3 weeks

All-transretinoic acid, 45mg/d Day4-Day6;15mg/d Day7-Day20

All-transretinoic acid

G-CSF 300ug,sc,Day 0 until CR is achieved

G-CSF

Ligen Liu

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

DLAAG in the Treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess

Clinical Efficacy and Safety of DLAAG Protocol in the Treatment of Refractory/Relapse of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess: a Multicenter, Single-arm, Prospective Clinical Study

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).

Morphologic leukemia-free state Bone marrow \<5% blasts in an aspirate with spicules No blasts with Auer rods or persistence of extramedullary disease

The time from the date of enrolling to the date of death due to any reasons or the last following date

the rate of adverse reaction, according to Standard for World Health Organization(WHO) acute and subacute toxicity

The time from the date of be hospitalized to the date of be discharged

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
DLAAG in the Treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess	NCT03356080	Acute Myeloid L... Myelodysplastic...	Decitabine Cytarabine All-transretino... G-CSF	18 Years - 90 Years	Shanghai Tong Ren Hospital
DLAAG in the Treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess	NCT03356080	Acute Myeloid L... Myelodysplastic...	Decitabine Cytarabine All-transretino... G-CSF	18 Years - 90 Years	Shanghai Tong Ren Hospital

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