Relapse and Refractory Acute Myelocytic Leukemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent; 2. Aged 3-59 years; 3. MICM is diagnosed as acute myeloid leukemia (AML), and meets the criteria for patients with relapsed or refractory AML (2016 NCCN guidelines); 4. Morphological or immunophenotyping of bone marrow cells of AML suggests that blast cells exceed 10%; 5. Receive allogeneic hematopoietic stem cell transplantation from a relative or unrelated donor.
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiac insufficiency and cardiac ejection fraction EF less than 60%; or severe arrhythmia, who cannot tolerate super preconditioning according to the investigator's evaluation; 2. With severe pulmonary insufficiency (obstructive and/or restrictive ventilation disorder), the investigator evaluates those who cannot tolerate super-strong conditioning regimens; 3. Accompanied by severe liver function impairment, liver function indexes (ALT, TBIL) are more than 3 times higher than the upper limit of normal (ULN); the investigators evaluate those who cannot tolerate super-strong conditioning regimens; 4. With severe renal insufficiency, the renal function index (Cr) is more than 2 times the upper limit of normal (ULN); or the 24-hour urinary creatinine clearance Ccr is lower than 50ml/min, and the investigators evaluate those who cannot tolerate the super-strong conditioning regimen; 5. Severe active infection before transplantation, and the investigators evaluate those who cannot tolerate preconditioning; 6. Allergic reactions or serious adverse reactions have occurred in the previous use of pretreatment-related drugs, and those who cannot be enrolled in the evaluation of the investigator; 7. Patients who are pregnant, planning to become pregnant or breastfeeding; 8. The investigator evaluates other reasons for not being selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival (OS) after transplantation;Leukemia free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity of the conditioning regimens;Recovery of neutrocyte;Recovery of platelet;Donor chimerism;Complete remission rate on day 28 after transplantation;Transplantation-realted mortality(1 year after transplantation);Relapse rate;Acute and chronic graft-versus-host disease (incidence and severity); | — |
Countries
China
Contacts
Aerospace Center Hospital