relapsed/refractory acute myeloid leukemia
Conditions
Interventions
VCA:VCA
Sponsors
Department of Hematology of The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Acute myeloid leukemia confirmed by histology. Refractory or recurrent AML, including: a Refractory disease will be defined as at least one previous treatment without remission. B Disease recurrence is defined as having 5% or more primitive cells in the bone marrow after remission. C AML patients caused by myelodysplastic syndromes (including CMML) or myeloproliferative tumors (secondary AML, t-AML) also meet the conditions; 2. Age = 18 years old, male or female, and the expected survival period is more than 3 months; 3. Estimated creatinine clearance = 50 mL/min; 4. AST and ALT = 3.0 x ULN (unless it is considered to be due to leukemia organ involvement). Bilirubin = 3.0 x ULN (unless it is considered to be due to leukemia organ involvement). 5.ECOG = 2; 6. Subjects took contraceptive measures during non-pregnancy or treatment; 7. Be able to understand and voluntarily provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia (APL); 2. Active central nervous system leukemia; 3. Patients with clinically significant QTc interval prolongation (male>450 ms; female>470 ms), ventricular tachycardia and atrial fibrillation, degree II heart block, myocardial infarction attack and congestive heart failure within one year before enrollment, and patients with coronary heart disease who have clinical symptoms and need drug treatment; 4. Active and uncontrolled serious infection; 5. Other non-myeloid malignancies within 2 years; 6. Mental disorders that may hinder research participation; 7. Previous solid organ transplantation (SCT treatment is allowed in advance, but not if the patient is GVHD or still receiving immunosuppression/GVHD treatment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| satety;objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Leukemia free survival;over all survival; | — |
Countries
China
Contacts
Public ContactBing Xu
The First Affiliated Hospital of Xiamen University
Outcome results
None listed