Status:
UNKNOWN
DLAAG in the Treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess
Lead Sponsor:
Shanghai Tong Ren Hospital
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 7 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03356080
Start Date
July 7 2017
End Date
July 7 2020
Last Update
November 29 2017
Active Locations (6)
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1
Beijing Friendship Hospital
Beijing, China
2
Fujian Medical University Union Hospital
Fuzhou, China
3
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
4
Shanghai Tong Ren hospital
Shanghai, China