myeloid malignancies
Conditions
Interventions
Case series:related-donor double negative T (DNT) cells
Sponsors
Department of Hematology, 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. The primary disease in patients was relapse after transplantation: leukemia cells were recurrence in peripheral blood or > 5% in bone marrow(except for other reasons such as bone marrow recovery, etc.), or extramedullary leukemia cell infiltration or recurrence of molecular biology or genetics; 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. Anti-HIV(-); 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; 9.Donor selection criteria: the related health donor, no requirement ofHLA matched loci.The relationships between donor and patient include:lineal and consanguineous relation, 3 acting less than about personnel of collateral line and consanguineous relation.
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. Patients with pregnancy; 4. suffered from II~IV acute GVHD or extensive chronic GVHD; 5.Systemic corticosteroids should be used in the extraction of peripheral blood, or cell infusion, which was allowed to use in other time periods; 6.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; 7. Participants and/or authorized family members refused to accept DNT immune cell therapy; 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: HIV positive, active hepatitis B or C, bone marrow disease, onset of mental illness, poison, drug addiction, refused to donate peripheral blood, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematopoietic cells recovery time;Duration of CR;Early mortality;1 year overall survival;1 year leukemia free survival;Minimal residual disease,WT - 1 gene, tumor gene, chromosome ebb and flow rate before and after treatment; | — |
Countries
China
Contacts
Public ContactZimin Sun
Anhui Provincial Hospital
Outcome results
None listed