Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT
This trial is active, not recruiting.
|Treatments||genetically modified dcs plus cik cells, donor leukocyte infusions (dli)|
|Phase||phase 1/phase 2|
|Sponsor||Affiliated Hospital to Academy of Military Medical Sciences|
|Start date||September 2013|
|End date||September 2016|
|Trial size||25 participants|
|Trial identifier||NCT01956630, 307-CTC-DC/CIK-Leukemia|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: up to 3 years
time frame: 100 days
Male or female participants from 8 years up to 61 years old.
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
|Official title||Clinical Study of Genetically Modified Dendritic Cells Combining to Cytokine-Induced Killer Cells for Patients With Relapse Acute Leukemia After Allo-HSCT|
|Principal investigator||Hu Chen, Doctor|
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