Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT
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|ClinicalTrials.gov Identifier: NCT01956630|
Recruitment Status : Unknown
Verified February 2016 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was: Active, not recruiting
First Posted : October 8, 2013
Last Update Posted : February 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemia||Biological: Genetically modified DCs plus CIK cells Biological: Donor leukocyte infusions (DLI)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Genetically Modified Dendritic Cells Combining to Cytokine-Induced Killer Cells for Patients With Relapse Acute Leukemia After Allo-HSCT|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||December 2016|
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)|
- Overall survival [ Time Frame: up to 3 years ]
- Gvhd incidence [ Time Frame: 100 days ]
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
|Department of Hematopoietic Stem Cell Transplantation|
|Beijing, China, 100071|
|Principal Investigator:||Hu Chen, Doctor||Affiliated Hospital to Academy of Military Medical Sciences|