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

Primary Purpose

Acute Leukemia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Genetically modified DCs plus CIK cells
Donor leukocyte infusions (DLI)
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia

Eligibility Criteria

8 Years - 61 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Hematopoietic Stem Cell Transplantation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Genetically modified DCs plus CIK cells

Donor leukocyte infusions (DLI)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Gvhd incidence

Full Information

First Posted
September 23, 2013
Last Updated
February 18, 2016
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01956630
Brief Title
Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT
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 Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genetically modified DCs plus CIK cells
Arm Type
Experimental
Arm Description
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.
Arm Title
Donor leukocyte infusions (DLI)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Genetically modified DCs plus CIK cells
Intervention Type
Biological
Intervention Name(s)
Donor leukocyte infusions (DLI)
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Gvhd incidence
Time Frame
100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hu Chen, Doctor
Organizational Affiliation
Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematopoietic Stem Cell Transplantation
City
Beijing
ZIP/Postal Code
100071
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29415891
Citation
Wang D, Huang XF, Hong B, Song XT, Hu L, Jiang M, Zhang B, Ning H, Li Y, Xu C, Lou X, Li B, Yu Z, Hu J, Chen J, Yang F, Gao H, Ding G, Liao L, Rollins L, Jones L, Chen SY, Chen H. Efficacy of intracellular immune checkpoint-silenced DC vaccine. JCI Insight. 2018 Feb 8;3(3):e98368. doi: 10.1172/jci.insight.98368. eCollection 2018 Feb 8.
Results Reference
derived

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

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