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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLAAG | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug | Decitabine,iv,0.1-0.2mg/kg, Day1-Day3 per week,up to 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CR) | Morphologic CR - patient independent of transfusions
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). | at the end of every course(about 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Early death rate | The rate of early death within 30 days | 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 |
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Inclusion Criteria:
corresponding to the AML (except M3) or high-risk MDS diagnostic criteria, with any of the following circumstances:
â‘ secondary 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.
â‘¢corresponding 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
â‘£corresponding to MDS refractory anemia with blasts excess (RAEB) diagnosis standards
Age ≥18 years old
Eastern Cooperative Oncology Group(ECOG) score 0-3
Expected survival ≥8 weeks
Patients must be able to understand and be willing to participate in this study, and signed informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ligen Liu | Contact | 18017337037 | llg3532@shtrhospital.com |
| Name | Affiliation | Role |
|---|---|---|
| Ligen Liu | Shanghai Tong Ren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Not yet recruiting | Beijing | China | |||
| Fujian Medical University Union Hospital |
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| Cytarabine | Drug | cytarabine, iv,15mg/m2 q12h, Day1-Day10 |
|
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| All-transretinoic acid | Drug | All-transretinoic acid, 45mg/d Day4-Day6;15mg/d Day7-Day20 |
|
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| G-CSF | Drug | G-CSF 300ug,sc,Day 0 until CR is achieved |
|
|
| 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 | 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 | from enrolling to the end of 2-year following up |
| Duration of hospitalization | The time from the date of be hospitalized to the date of be discharged | 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 | from enrolling to the end of 2-year following up |
| Not yet recruiting |
| Fuzhou |
| China |
| The People's Hospital of Guangxi Zhuang Autonomous Region | Not yet recruiting | Nanning | China |
| Shanghai Tong Ren hospital | Recruiting | Shanghai | China |
|
| The center hospital of Shanghai Fengxian District | Not yet recruiting | Shanghai | China |
| First Affiliated Hospital of Zhengzhou University. | Not yet recruiting | Zhengzhou | China |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| D003561 | Cytarabine |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D001087 | Arabinonucleosides |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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