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NCT01956630 Clinical Trial

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

Acute Leukemia Clinical Trial

Official title:
Clinical Study of Genetically Modified Dendritic Cells Combining to Cytokine-Induced Killer Cells for Patients With Relapse Acute Leukemia After Allo-HSCT

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01956630
Other study ID # 307-CTC-DC/CIK-Leukemia
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received September 23, 2013
Last updated February 18, 2016
Start date September 2013
Est. completion date December 2016

Study information
Verified date February 2016
Source Affiliated Hospital to Academy of Military Medical Sciences
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 25
Est. completion date December 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 61 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Genetically modified DCs plus CIK cells

• Donor leukocyte infusions (DLI)

Locations
Country Name City State
China Department of Hematopoietic Stem Cell Transplantation Beijing

Sponsors (1)
Lead Sponsor Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival up to 3 years No
Secondary Gvhd incidence 100 days Yes
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