Trial record 16 of 16 for:    WAGR

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Affiliated Hospital to Academy of Military Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT01956630
First received: September 23, 2013
Last updated: September 30, 2013
Last verified: September 2013
  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 combined with CIK cells
Biological: Donor leukocyte infusions (DLI)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gvhd incidence [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

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 combined with 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 combined with 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

Ages Eligible for Study:   8 Years to 61 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01956630

Contacts
Contact: Dan Hong Wang, Master +86-010-6694-7102 wangdh307@sina.com

Locations
China
Department of Hematopoietic Stem Cell Transplantation Recruiting
Beijing, China, 100071
Contact: Bin Zhang, Doctor    +86-010-6694-7125    zb307ctc@163.com   
Principal Investigator: Hu Chen, Doctor         
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

No publications provided

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
Study First Received: September 23, 2013
Last Updated: September 30, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 29, 2014