Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences Identifier:
First received: September 23, 2013
Last updated: February 18, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Acute Leukemia
Biological: Genetically modified DCs plus CIK cells
Biological: Donor leukocyte infusions (DLI)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Genetically Modified Dendritic Cells Combining to Cytokine-Induced Killer Cells for Patients With Relapse Acute Leukemia After Allo-HSCT

Resource links provided by NLM:

Further study details as provided by Affiliated Hospital to Academy of Military Medical Sciences:

Primary Outcome Measures:
  • Overall survival [ Time Frame: up to 3 years ]

Secondary Outcome Measures:
  • Gvhd incidence [ Time Frame: 100 days ]

Estimated Enrollment: 25
Study Start Date: September 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: Genetically modified DCs plus CIK cells
Active Comparator: 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.
Biological: Donor leukocyte infusions (DLI)


Ages Eligible for Study:   8 Years to 61 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01956630

Department of Hematopoietic Stem Cell Transplantation
Beijing, China, 100071
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Principal Investigator: Hu Chen, Doctor Affiliated Hospital to Academy of Military Medical Sciences
  More Information

Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences Identifier: NCT01956630     History of Changes
Other Study ID Numbers: 307-CTC-DC/CIK-Leukemia
Study First Received: September 23, 2013
Last Updated: February 18, 2016

Additional relevant MeSH terms:
Acute Disease
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes processed this record on May 25, 2017