Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MRD-directed Donor Lymphocyte Infusion for Reduce of Relapse After Allo-HSCT

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.
 
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
Sponsor:
Collaborators:
Guangzhou First People's Hospital
Zhujiang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Peking University People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Brief Summary:
Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse remains an important problem. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI), and another transplantation used alone or in combination. However, the efficacy of these interventions is limited. One approach to the relapse problem is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (MRD). In this study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in patients with acute leukemia receiving allo-HSCT.

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

Detailed Description:
Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse remains an important problem. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI), and another transplantation used alone or in combination. However, the efficacy of these interventions is limited. One approach to the relapse problem is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (MRD) using immune or molecular techniques.DLI is an effective post-transplantation therapy for prophylaxis of leukemia relapse, but is associated with a substantial risk of GVHD. Whether MRD-directed DLI could improve outcomes remains unclear. In this study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in patients with acute leukemia receiving allo-HSCT.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. relapse rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 1 year ]
  2. disease-free survival [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with acute leukemia
  • receiving allo-HSCT

Exclusion Criteria:

  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  • Patients with any conditions not suitable for the trial (investigators' decision)

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): NCT02673008


Contacts
Layout table for location contacts
Contact: Li Xuan 356135708@qq.com

Locations
Layout table for location information
China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Li Xuan    +86-020-61641613    356135708@qq.com   
Principal Investigator: Qifa Liu         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Guangzhou First People's Hospital
Zhujiang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Peking University People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
Layout table for investigator information
Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University

Publications:
Layout table for additonal information
Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02673008     History of Changes
Other Study ID Numbers: MRD-directed DLI-2016
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm, Residual
Recurrence
Disease Attributes
Pathologic Processes
Neoplastic Processes
Neoplasms