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

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01956630

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Leukemia	Biological: Genetically modified DCs plus CIK cells Biological: Donor leukocyte infusions (DLI)	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Genetically modified DCs plus CIK cells Patients received four subcutaneous injections of 2-5×10e7 cells of DCs at the groin, axilla, and neck respectively on days 7, 9, 11, and 13 and i.v. infusions of 2-15×10e9 CIK on days 11 and 13 per cycle. The cycle was repeated until Wilms' tumor 1(WT1) turned negative by polymerase chain reaction(PCR) or graft-versus-host disease(GVHD) appeared.	Biological: Genetically modified DCs plus CIK cells
Active Comparator: Donor leukocyte infusions (DLI) Patients received DLI at a dose of 2×10e7/kg, 5×10e7/kg and 1×10e8/kg cluster of differentiation 3(CD3)+ cells at months 1, 2 and 3 respectively unless GVHD appeared.	Biological: Donor leukocyte infusions (DLI)

Arm

Intervention/Treatment

Experimental: Genetically modified DCs plus CIK cells

Patients received four subcutaneous injections of 2-5×10e7 cells of DCs at the groin, axilla, and neck respectively on days 7, 9, 11, and 13 and i.v. infusions of 2-15×10e9 CIK on days 11 and 13 per cycle. The cycle was repeated until Wilms' tumor 1(WT1) turned negative by polymerase chain reaction(PCR) or graft-versus-host disease(GVHD) appeared.

Biological: Genetically modified DCs plus CIK cells

Active Comparator: Donor leukocyte infusions (DLI)

Patients received DLI at a dose of 2×10e7/kg, 5×10e7/kg and 1×10e8/kg cluster of differentiation 3(CD3)+ cells at months 1, 2 and 3 respectively unless GVHD appeared.

Biological: Donor leukocyte infusions (DLI)

Outcome Measures

Primary Outcome Measures

Overall survival [up to 3 years]

Secondary Outcome Measures

Gvhd incidence [100 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 61 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hematopoietic Stem Cell Transplantation	Beijing		China	100071

Sponsors and Collaborators

Affiliated Hospital to Academy of Military Medical Sciences

Investigators

Principal Investigator: Hu Chen, Doctor, Affiliated Hospital to Academy of Military Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Affiliated Hospital to Academy of Military Medical Sciences

ClinicalTrials.gov Identifier:

NCT01956630

Other Study ID Numbers:

307-CTC-DC/CIK-Leukemia

First Posted:

Oct 8, 2013

Last Update Posted:

Feb 22, 2016

Last Verified:

Feb 1, 2016

Additional relevant MeSH terms:

Leukemia

Acute Disease

Study Results

No Results Posted as of Feb 22, 2016