Overview

This trial is active, not recruiting.

Condition acute leukemia
Treatments genetically modified dcs plus cik cells, donor leukocyte infusions (dli)
Phase phase 1/phase 2
Sponsor Affiliated Hospital to Academy of Military Medical Sciences
Start date September 2013
End date September 2016
Trial size 25 participants
Trial identifier NCT01956630, 307-CTC-DC/CIK-Leukemia

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
genetically modified dcs plus cik cells
(Active Comparator)
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.
donor leukocyte infusions (dli)

Primary Outcomes

Measure
Overall survival
time frame: up to 3 years

Secondary Outcomes

Measure
Gvhd incidence
time frame: 100 days

Eligibility Criteria

Male or female participants from 8 years up to 61 years old.

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

Additional Information

Official title Clinical Study of Genetically Modified Dendritic Cells Combining to Cytokine-Induced Killer Cells for Patients With Relapse Acute Leukemia After Allo-HSCT
Principal investigator Hu Chen, Doctor
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Affiliated Hospital to Academy of Military Medical Sciences.