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Modified DLI (donor double negative T cells) in the treatment of relapse after allogeneic hematopoietic stem cell transplantation of myeloid malignancies single clinical research center

Modified DLI (donor double negative T cells) in the treatment of myeloid malignancies relapse after allogeneic hematopoietic stem cell transplantation single clinical research center

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONB-15007431
Enrollment
Unknown
Registered
2015-11-18
Start date
2015-09-10
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myeloid malignancies

Interventions

DNT treatment group:donor DNT cells infusion

Sponsors

Department of Hematology, Anhui Provincial Hospital
Lead Sponsor

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. STR PCR results show that there is still a donor cell; 6. Karnofsky score 60% or higher, eastern group (ECOG) tumor physical status score 0 to 2 points; 7. 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); 8. Anti-HIV(-); 9. 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.

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. 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; 5. Participants and/or authorized family members refused to accept DNT immune cell therapy; 6. Participate in other clinical researches in 3 months; 7. Researchers think that the patient doesn't fit into the group (e.g., patients are expected to be discontinue because of funding problems).

Design outcomes

Primary

MeasureTime frame
complete remission;

Secondary

MeasureTime 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
zmsun_vip@163.com+86 18963789126

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026