Hematologic malignacy
Conditions
Interventions
1:azacitidine treatment
2:modified donor lymphocyte infusion treatment
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years old; 2. Patients with AML or MDS diagnosed according to WHO diagnostic criteria; 3. Patients who received allogeneic hematopoietic stem cell transplantation and achieved complete remission and MRD negative: MRD (MFC =3log, others =CR3 or NCR); (3) Relapse after the first allogeneic hematopoietic stem cell transplantation; (4) At the time of transplantation, MRD was positive (MFC > 0.1%) and / or fusion gene and gene mutation (WT1 > 0.6%, aml1eto > 0.4%, CBF beta - myh11 decreased 1%); 5. Patients with complex karyotype chromosomal abnormalities; 6. Patients with expected survival time >=3 months; 7. Good organ function level: ANC (neutrophil absolute value >=1.0x10^9/L; PLT >=70x10^9/L; HB >=80g/L; Tibil =50%) 8. Patients who have received any anti-tumor treatment (including radiotherapy, chemotherapy, surgery or molecular targeted treatment) for more than 4 weeks from the end of the previous treatment; 9. Patients with no GVHD and no previous history of 3 or more degrees of aGVHD; 10. Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiac insufficiency and EF lower than 60%; or patients with severe arrhythmia who could not tolerate super pretreatment; 2. Patients with flt3-itd positive or bcr-abl positive; 3. Patients with MRD positive (MFC > 0.1%) and / or fusion gene and gene mutation (WT1 > 0.6%, aml1eto > 0.4%, CBF beta - myh11 decreased 1%); 4. Patients who were previously known to be resistant to azacytidine or dessicabine; 5. In patients with severe pulmonary insufficiency (obstructive and / or restrictive ventilation disorders), the researchers evaluated the patients who could not tolerate the super pretreatment scheme; 6. Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of super pretreatment; 7. In patients with severe renal insufficiency, the renal function index (CR) is more than 2 times of the upper limit of the normal value (ULN), or the 24-hour creatinine clearance rate (CR) is less than 50ml / min, the researchers evaluated that they could not tolerate the super pretreatment scheme; 8. In patients with severe active infection, the researchers evaluated that they could not tolerate the pretreatment; 9. Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study; 10. Patients with hematological recurrence (bone marrow smear: proportion of primordial cells >=5%) or any extramedullary recurrence; 11. Other reasons why the researchers could not be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| graft-versus-host disease -free relapse-free survival;relapse-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactHe Huang/ Yi Luo
The First Affiliated Hospital of Zhejiang University Medical College
Outcome results
None listed