myeloid malignancies
Conditions
Interventions
case series:DNT cells
Sponsors
The First Affiliated Hospital of USTC, Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Any age, any gender, any race; 2. Myeloid malignancies including acute myeloid leukemia(AML)(except APL), myelodysplastic syndrome (MDS), myelodysplastic syndrome(MDS/MPD)/bone marrow hyperplastic disease, chronic myelogenous leukemia (CML), all patients were diagnosed through MICM (in accordance with the WHO diagnostic criteria); 3. All the patients were treated with HSCT; 4. One of the risk factors for recurrence after transplantation: Disease-related factors: if diagnosed as AML, it meets one of the following factors: (1) high-risk group of cytogenetics; (2) monomer karyotype; (3) flt3-itd mutation; (4) MDS to AML; (5) patients with unrelieved disease before transplantation; (6) positive MRD before transplantation; If diagnosed as MDS: medium or high risk of IPSS score; If diagnosed as CML: (1) treatment failure of tyrosine kinase inhibitor; (2) progress to the acceleration phase or the abrupt change phase; 5. Karnofsky score 60% or higher, eastern group (ECOG) tumor physical status score 0 to 2 points; 6. In group 2 weeks before the serum total bilirubin <=1.5 times of normal cap (of the same age group);Alanine aminotransferase (ALT) and aspertate aminotransferase (AST) <=3times of normal cap (of the same age group); Serum creatinine<=2 times of normal cap (of the same age group); Myocardial enzyme < 2 times of normal cap (of the same age group); 7. If the recurrence of allogenic hematopoietic stem cell transplantation reached complete remission after induction chemotherapy, STR-PCR showed complete donor chimerism, MRD negative, and could also be enrolled; 8. Each participant must sign a consent form (ICF), shows that he/she understand the study purpose and procedures, and are willing to participate in research; Considering from the patient, if the signature is not conducive to patient treatment, it is signed by the legal representative of ICF. Donor selection criteria: 1. Aged = 18 years; 2. Qualified health personnel who meet the blood donation requirements of the central blood station; 3. No disease transmitted through the blood system within 30 days before blood collection (HIV negative, HBsAg negative, HBV core antibody negative, hepatitis C antibody negative, syphilis serological test negative, CMV-IgM negative, EBV-IgM negative); 4. Agree to donate peripheral blood.
Exclusion criteria
Exclusion criteria: 1. Any serious complications, such as pulmonary infection, or diseases (such as uncontrolled diabetes, etc.); 2. Serious viscera dysfunction or disease, such as serious diseases and function disorder in heart, liver, kidney and pancreas;3. HIV positive, active hepatitis B or C; 4. Grade II ~ IV acute GVHD appear during DNT infusion; 5. The dosage of hormone was higher than 0.5mg/kg/d of methylprednisolone or equal amount of prednisone or equal dexamethasone in the infusion; 6. Patients with pregnancy; 7. Researchers believe that can damage the unnecessary risks to safety, make the results of the study subjects any life-threatening illness, condition or organ system dysfunction; drug dependence; uncontrolled mental disease ; cognitive impairment; 8. Participate in other clinical researches in 3 months; 9. Researchers think that the patient doesn't fit into the group (e.g., patients are expected to be discontinue because of funding problems); 10. The donor does not meet the requirements: chronic diseases that need to be treated (such as hypertension, diabetes, heart disease, thyroid disease and liver and kidney dysfunction), bone marrow disease,systemic corticosteroids must be used in Peripheral blood extraction,onset of mental illness, poison, drug addiction, refused to donate peripheral blood, etc..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulativerelapserate after 6 months of infusion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative incidence of II~IV or III~IV aGVHD;Reconstruction of immune function;100d non-recurrent mortality ;Cumulative incidence of cGVHD;1 year overall survival;1 year leukemia free survival; | — |
Countries
China
Contacts
Public ContactXiaoyu Zhu
The First Affiliated Hospital of USTC, Anhui Provincial Hospital
Outcome results
None listed