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

Phase 1

• Conditions: Acute Leukemia
• Interventions: Biological: Donor leukocyte infusions (DLI); Biological: Genetically modified DCs plus CIK cells

• Registration Number: NCT01956630
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-09-30
• Study First Posted: 2013-10-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-22
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Donor leukocyte infusions (DLI)	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.
Genetically modified DCs plus CIK cells	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	up to 3 years

Secondary Outcome Measures

Name	Time	Method
Gvhd incidence	100 days

Trial Locations

Locations (1)

Department of Hematopoietic Stem Cell Transplantation; 🇨🇳 Beijing, China