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

NCT ID: NCT01956630

Last Updated: 2016-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Genetically modified DCs plus CIK cells

Intervention Type BIOLOGICAL

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.

Group Type ACTIVE_COMPARATOR

Donor leukocyte infusions (DLI)

Intervention Type BIOLOGICAL

Interventions

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Genetically modified DCs plus CIK cells

Intervention Type BIOLOGICAL

Donor leukocyte infusions (DLI)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hu Chen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital to Academy of Military Medical Sciences

Locations

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Department of Hematopoietic Stem Cell Transplantation

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 29415891 (View on PubMed)

Other Identifiers

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307-CTC-DC/CIK-Leukemia

Identifier Type: -

Identifier Source: org_study_id

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