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

NCT01956630 | Unknown Phase 1 DMC

• 1 other identifier: 307-CTC-DC/CIK-Leukemia
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall survival

  up to 3 years

Secondary Outcomes (1)

• Gvhd incidence

  100 days

Study Arms (2)

Genetically modified DCs plus CIK cells

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.

Biological: Genetically modified DCs plus CIK cells

Donor leukocyte infusions (DLI)

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.

Biological: Donor leukocyte infusions (DLI)

Interventions

Genetically modified DCs plus CIK cells BIOLOGICAL

Genetically modified DCs plus CIK cells

Donor leukocyte infusions (DLI) BIOLOGICAL

Donor leukocyte infusions (DLI)

Eligibility Criteria

• Age: 8 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• AL patients according to the WHO criteria
• expected survival duration of more than 3 months
• age between 8 and 61years

You may not qualify if:

• underlying autoimmune disease
• positive serology for HIV infection
• chronic active hepatitis

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

Department of Hematopoietic Stem Cell Transplantation

Beijing, 100071, China

Location

Related Publications (1)

• 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.

  PMID: 29415891 DERIVED

Study Officials

• Hu Chen, Doctor

  Affiliated Hospital to Academy of Military Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

CN (1)