leukemia
Conditions
Interventions
Cell infusion group:Children with high risk of leukemia before transplantation, intravenous infusion of cells after transplantation
Donors:Nil
Sponsors
Beijing Jingdu Children's Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. The subjects 1) Aged 1-18 years; 2) Meet the requirements of hematopoietic stem cell transplantation; 3) Meet the definition of children's high-risk acute leukemia before inclusion (Specification for diagnosis and treatment of children's acute lymphoblastic leukemia 2018, cclg-aml 2016); 4) Donor signs informed consent for donation of peripheral blood; 5) The recipient's family members sign the informed consent form for clinical trial 2. The Donor: 1) Aged less than 50 years; 2) For women in childbearing period, serum or urine should be tested within 7 days before entering the group, and pregnancy test is negative; 3) Women in non lactation; 4) No serious liver, heart and kidney dysfunction; 5) Signing the informed consent of peripheral blood collection.
Exclusion criteria
Exclusion criteria: 1. The subjects: 1) Has received immunocell therapy, including dendritic cells (DC), cytokine induced cells (CIK), cytotoxic T lymphocytes (CTL) or other types of immunocell therapy; 2) Previous allergic history of recombinant human IL-2; 3) Severe GVHD occurred after transplantation. Hormone and other immunosuppressants could not be stopped on the day of intravenous infusion; 4) With infection and serious dysfunction of liver, heart, kidney and other major organs. 2. The Donor: 1) Pregnant or nursing women; 2) Hepatitis B, hepatitis C, Treponema pallidum, HIV positive; 3) Heart, liver, kidney and other important organ dysfunction; 4) The immunosuppression was too heavy, such as methylprednisolone more than 10mg/d.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| physical examination;vital signs;Adverse reaction assessment;MDR tests for leukemia in blood and bone marrow (and cerebrospinal fluid);Detection of chimerism rate;Peripheral blood CD3+/CD4+/CD8+ subsets were monitored by immune reconstruction;NK cells;Number of B lymphocytes;immunoglobulin; | — |
Countries
China
Contacts
Public ContactSun Yuan
Beijing Jingdu Children's Hospital
Outcome results
None listed