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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01956630
First Posted: October 8, 2013
Last Update Posted: February 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences
  Purpose
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: None (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)

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956630


Locations
China
Department of Hematopoietic Stem Cell Transplantation
Beijing, China, 100071
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Investigators
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
ClinicalTrials.gov Identifier: NCT01956630     History of Changes
Other Study ID Numbers: 307-CTC-DC/CIK-Leukemia
First Submitted: September 23, 2013
First Posted: October 8, 2013
Last Update Posted: February 22, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes