Acute meyloid leukemia
Conditions
Interventions
Intervention group:Azacytidine and pomalidomide
Sponsors
Second Affiliated Hospital, Army Medical University, PLA
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of acute myeloid leukemia, except for acute promyelocytic leukemia; 2. 18-60 years old, male or female; 3. Having undergone allogeneic hematopoietic stem cell transplantation with hematopoietic reconstruction; 4. Routine bone marrow examination after transplantation demonstrates morphological remission with measurable residual disease judged by abnormal phenotype detected by flow cytometry, fusion gene by polymerase chain reaction, mutated gene by sequencing; 5. No de novo grade II-IV acute graft-versus-host disease within 3 months before enrollment (except for skin graft-versus-host disease, but the grade must be decreased to grade I or below grade I for at least 1 month). For patients who had occurrence of acute graft-versus-host disease 3 months before enrollment, the grade of skin graft-versus-host disease must be reduced to grade I or below grade I for at least 1 month, and the grade of gastrointestinal or liver must be reduced to grade 0 for at least 1 month; 6. No active moderate to severe chronic graft-versus-host disease assessed by NIH criteria; 7. No active infection requiring intravenous anti-infection treatment; 8. No organ dysfunction; 9. Volunteer to participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of extramedullary recurrence by imaging and pathological biopsy; 2. Previous diagnosis of central nervous system leukemia; 3. Impaired renal or hepatic function (defined as total bilirubin greater than 3 times the upper limit of normal (ULN), aspartate aminotransferase or alanine aminotransferase greater than 3 times the ULN, serum creatinine greater than 2 times the ULN or glomerular filtration rate less than 40 ml/min); 4. History of thrombotic disease or risk of thrombosis assessed by the investigator; 5. Received other antitumor therapy within 28 days of the protocol treatment, except for hypomethylating agent; 6. Hypersensitivity to research drug or presence of other contraindications to azacytidine and/or pomalidomide; 7. Poor compliance; 8. Other conditions that the investigators deem unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival at 6 months after treatment start; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major response rate (MRD negativity);Minor response rate (MRD positivity without relapse);Relapse-free survival at 1 year after treatment start;Overall survival at 1 year after treatment start;Incidence of acute graft-versus-host disease;Incidence of chronic graft-versus-host disease;Incidence of grade 3-4 hematological adverse events;Incidence of other grade 3-4 adverse events;Proportion of lymphocyte subset; | — |
Countries
China
Contacts
Public ContactGao Lei, Kong Peiyan
Second Affiliated Hospital, Army Medical University, PLA
Outcome results
None listed