MRD-directed Donor Lymphocyte Infusion for Reduce of Relapse After Allo-HSCT
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|ClinicalTrials.gov Identifier: NCT02673008|
Recruitment Status : Unknown
Verified January 2016 by Qifa Liu, Nanfang Hospital of Southern Medical University.
Recruitment status was: Recruiting
First Posted : February 3, 2016
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Minimal Residual Disease Donor Lymphocyte Infusion Hematopoietic Stem Cell Transplantation Relapse||Biological: donor lymphocyte infusion||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Minimal Residual Disease-directed Donor Lymphocyte Infusion for Reduce of Relapse After Allogenetic Hematopoietic Stem Cell Transplantation|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: MRD-directed DLI
For patients with MRD+ and without grade II/>II aGVHD by day +60 post-transplantation, DLI was given once by day +60 and was then administered based on MRD and GVHD status. If patients were MRD negative, DLI was not given again; if patients were MRD positive and without GVHD, DLI was given monthly until GVHD occurred or MRD became negative or for a total of four times. For patients with NR or PR pre-transplantation and with MRD negative by day +60 post-transplantation, DLI was given once by day +90 regardless of MRD, and was then administered when MRD became positive. For patients with CR pre-transplantation and with MRD negative post-transplantation, DLI was not given unless MRD became positive.
Biological: donor lymphocyte infusion
DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10*8 mononuclear cells/kg.
- relapse rate [ Time Frame: 1 year ]
- overall survival [ Time Frame: 1 year ]
- disease-free survival [ Time Frame: 1 year ]
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): NCT02673008
|Contact: Li Xuanemail@example.com|
|Department of Hematology,Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: Li Xuan +86-020-61641613 firstname.lastname@example.org|
|Principal Investigator: Qifa Liu|
|Principal Investigator:||Qifa Liu||Nanfang Hospital of Southern Medical University|