drugset / Trial / NCT01956630

Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT

NCT01956630

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-09
Primary completion
2016-09
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CIK cells Cell therapy 2e+09 cells Intravenous
Subject CIK cells Cell therapy 1.5e+10 cells Intravenous
Subject Genetically modified DCs Vaccine 2e+07 cells Subcutaneous
Subject Genetically modified DCs Vaccine 5e+07 cells Subcutaneous

Indications