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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Complete Response Rate (CR)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •acute promyelocytic leukemia (M3 type)
- •Other types of MDS patients except RAEB
- •with other advanced malignant tumors
- •patients with uncontrolled severe infection, and can not tolerate chemotherapy with other serious underlying diseases
- •patients with heart failure: ejection fraction (EF) < 30%, New York Heart Association(NYHA) standard, cardiac insufficiency in class II or above
研究组 & 干预措施
DLAAG
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
干预措施: Decitabine (Drug)
DLAAG
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
干预措施: Cytarabine (Drug)
DLAAG
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
干预措施: All-transretinoic acid (Drug)
DLAAG
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
干预措施: G-CSF (Drug)
结局指标
主要结局
Complete Response Rate (CR)
时间窗: 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).
次要结局
- Duration of hospitalization(from enrolling to the end of 2-year following up)
- The rate of adverse reaction the rate of adverse reaction(from enrolling to the end of 2-year following up)
- Early death rate(the death rate after treating Day1 to Day30)
- Leukemia free survival (LFS)(from enrolling to the end of 2-year following up)
- Overall survival(OS)(from enrolling to the end of 2-year following up)
- The rate of relapse(from enrolling to the end of 2-year following up)
研究者
Liu Ligen
head of hematology department
Shanghai Tong Ren Hospital