Clinical trial NCT03356080: DLAAG in the Treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Keywords: decitabine
retinoid acid
cytarabine C
Granulocyte Colony Stimulating Factor
acute myeloid leukemia
Myelodysplastic Syndrome
Lead sponsor: Shanghai Tong Ren Hospital
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Complete Response Rate (CR)
timeFrame: at the end of every course(about 4 weeks)
Secondary outcomes:
measure: Early death rate
timeFrame: the death rate after treating Day1 to Day30
measure: Leukemia free survival (LFS)
timeFrame: from enrolling to the end of 2-year following up
measure: Overall survival(OS)
timeFrame: from enrolling to the end of 2-year following up
measure: The rate of adverse reaction the rate of adverse reaction
timeFrame: from enrolling to the end of 2-year following up
measure: Duration of hospitalization
timeFrame: from enrolling to the end of 2-year following up
measure: The rate of relapse
timeFrame: from enrolling to the end of 2-year following up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
city: Shanghai
country: China
facility: Shanghai Tong Ren hospital
city: Shanghai
country: China
facility: The center hospital of Shanghai Fengxian District
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University.
Study officials:
affiliation: Shanghai Tong Ren Hospital
name: Ligen Liu
role: PRINCIPAL_INVESTIGATOR
References: