Low-risk acute myeloid leukemia with minimal residual disease positive after allogeneic hematopoietic stem cell transplantation
Conditions
Interventions
Case series:NA
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: ? Low-risk AML according to ELN 2022, including AML with RUNX1-RUNX1T1, CBFß-MYH11, NPM1 ? 12-65 years old ? Achieving CR1 but with persistently MRD positive before transplantation, or achieving CR2 or above before transplantation, with or without MRD positive before transplantation ? After transplantation, consecutive molecular markers increases twice in 2 weeks, including RUNX1-RUNX1T1: a decrease of 0.4%) from baseline, but a decrease of = 2 logs (= 4%); CBFß-MYH11: a decrease of 0.2%) from baseline, but a decrease of = 2 logs (= 2%); NPM1: > 0.0% and = 1% ? Received preemptive interferon-a therapy according to clinical routine
Exclusion criteria
Exclusion criteria: 1: Did not achieve CR before transplantation 2: MFC positive (= 0.01%) after transplantation 3: RUNX1-RUNX1T1 or CBFß-MYH11 level decreased < 2 logs from baseline 4: With active GVHD (II-IV degree aGVHD, moderate to severe cGVHD) 5: With uncontrolled active infections 6: With important organ dysfunction 7: With severe bone marrow suppression (WBC < 1.0 × 10^9/L, ANC < 0.5 × 10^9/L, HB < 65 g/L or PLT < 25 × 10^9/L) 8: Participated in other clinical studies within one month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year relapse rate after interferon-a therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| MRD turning negative rate after interferon-a therapy;Incidence rate of GVHD;Leukemia free survival;Overall survival;Non-relapse mortality rate;Adverse event occurrence rate; | — |
Countries
China
Contacts
Public ContactXiaodong Mo
Peking University People’s Hospital
Outcome results
None listed