Acute Leukemia
Conditions
Brief summary
Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient survival, is so far treated by second transplantation and donor leukocyte infusion (DLI), which seems to have high risk and low survival. Need for a new medication on relapse is urgent. The immunotherapy using Dendritic cells (DCs) combined with cytokine induced killer (CIK) cells holds promise for the adjuvant treatment of AL to eradicate or control residual disease. This randomized study was conducted to evaluate the feasibility and effective of genetically modified DCs combining to CIK immunotherapy in relapse AL after allo-HSCT.
Interventions
BIOLOGICALGenetically modified DCs plus CIK cells
BIOLOGICALDonor leukocyte infusions (DLI)
Sponsors
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 61 Years
Healthy volunteers
No
Inclusion criteria
* AL patients according to the WHO criteria * expected survival duration of more than 3 months * age between 8 and 61years
Exclusion criteria
* underlying autoimmune disease * positive serology for HIV infection * chronic active hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Gvhd incidence | 100 days |
Countries
China
Outcome results
None listed