Acute Myeloid Leukemia, Myelodysplastic Syndrome
Conditions
Keywords
decitabine, retinoid acid, cytarabine C, Granulocyte Colony Stimulating Factor, acute myeloid leukemia, Myelodysplastic Syndrome
Brief summary
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
Interventions
DRUGDecitabine
Decitabine,iv,0.1-0.2mg/kg, Day1-Day3 per week,up to 3 weeks
DRUGCytarabine
cytarabine, iv,15mg/m2 q12h, Day1-Day10
DRUGAll-transretinoic acid
All-transretinoic acid, 45mg/d Day4-Day6;15mg/d Day7-Day20
DRUGG-CSF
G-CSF 300ug,sc,Day 0 until CR is achieved
Sponsors
Shanghai Tong Ren Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. corresponding to the AML (except M3) or high-risk MDS diagnostic criteria, with any of the following circumstances: ①secondary AML patients (including AML secondary to MDS) ②corresponding to refractory AML diagnostic standard ( relapsed refractory acute myeloid leukemia Chinese guidelines(2017 Edition): Refractory AML diagnostic criteria: invalid after standard treatment 2 cycles of untreated cases; consolidation therapy after CR and then recurrence within 12 months; recurrence after 12 months and then invalid after conventional chemotherapy ; relapse of ≥ 2 times ; extramedullary leukemia continued existence. ③corresponding to recurrent AML diagnostic criteria (relapsed refractory acute myeloid leukemia China guidelines (2017 Edition): peripheral blood leukemia cells or bone marrow progenitor cells appear again \> 0.050 after CR (with the exception of bone marrow regeneration after consolidation chemotherapy and other reasons) or leukemia cells infiltration appear in extramedullary ④corresponding to MDS refractory anemia with blasts excess (RAEB) diagnosis standards 2. Age ≥18 years old 3. Eastern Cooperative Oncology Group(ECOG) score 0-3 4. Expected survival ≥8 weeks 5. Patients must be able to understand and be willing to participate in this study, and signed informed consent
Exclusion criteria
1. acute promyelocytic leukemia (M3 type) 2. Other types of MDS patients except RAEB 3. with other advanced malignant tumors 4. patients with uncontrolled severe infection, and can not tolerate chemotherapy with other serious underlying diseases 5. patients with heart failure: ejection fraction (EF) \< 30%, New York Heart Association(NYHA) standard, cardiac insufficiency in class II or above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate (CR) | at the end of every course(about 4 weeks) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leukemia free survival (LFS) | from enrolling to the end of 2-year following up | Morphologic leukemia-free state Bone marrow \<5% blasts in an aspirate with spicules No blasts with Auer rods or persistence of extramedullary disease |
| Overall survival(OS) | from enrolling to the end of 2-year following up | The time from the date of enrolling to the date of death due to any reasons or the last following date |
| Early death rate | the death rate after treating Day1 to Day30 | The rate of early death within 30 days |
| Duration of hospitalization | from enrolling to the end of 2-year following up | The time from the date of be hospitalized to the date of be discharged |
| The rate of relapse | from enrolling to the end of 2-year following up | 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 |
| The rate of adverse reaction the rate of adverse reaction | from enrolling to the end of 2-year following up | the rate of adverse reaction, according to Standard for World Health Organization(WHO) acute and subacute toxicity |
Countries
China
Contacts
Primary ContactLigen Liu
Outcome results
None listed