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

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Acute Leukemia

Treatments: Biological: Genetically modified DCs plus CIK cells; Biological: Donor leukocyte infusions (DLI)

Study type: Interventional

Funder types: Other

Identifiers

NCT01956630

307-CTC-DC/CIK-Leukemia

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 8 to 61 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Genetically modified DCs plus CIK cells

Experimental group

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.

Treatment:

Biological: Genetically modified DCs plus CIK cells

Donor leukocyte infusions (DLI)

Active Comparator group

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.

Treatment:

Biological: Donor leukocyte infusions (DLI)