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

Primary Purpose

Minimal Residual Disease, Donor Lymphocyte Infusion, Hematopoietic Stem Cell Transplantation

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
donor lymphocyte infusion
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Minimal Residual Disease

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Hematology,Nanfang Hospital, Southern Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRD-directed DLI

Arm Description

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.

Outcomes

Primary Outcome Measures

relapse rate

Secondary Outcome Measures

overall survival
disease-free survival

Full Information

First Posted
January 23, 2016
Last Updated
February 24, 2020
Sponsor
Nanfang Hospital, Southern Medical University
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
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1. Study Identification

Unique Protocol Identification Number
NCT02673008
Brief Title
MRD-directed Donor Lymphocyte Infusion for Reduce of Relapse After Allo-HSCT
Official Title
Minimal Residual Disease-directed Donor Lymphocyte Infusion for Reduce of Relapse After Allogenetic Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 25, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Residual Disease, Donor Lymphocyte Infusion, Hematopoietic Stem Cell Transplantation, Relapse

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRD-directed DLI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
donor lymphocyte infusion
Intervention Description
DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10*8 mononuclear cells/kg.
Primary Outcome Measure Information:
Title
relapse rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
1 year
Title
disease-free survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qifa Liu
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology,Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22337715
Citation
Yan CH, Liu DH, Liu KY, Xu LP, Liu YR, Chen H, Han W, Wang Y, Qin YZ, Huang XJ. Risk stratification-directed donor lymphocyte infusion could reduce relapse of standard-risk acute leukemia patients after allogeneic hematopoietic stem cell transplantation. Blood. 2012 Apr 5;119(14):3256-62. doi: 10.1182/blood-2011-09-380386. Epub 2012 Feb 14.
Results Reference
background
PubMed Identifier
35467818
Citation
Fan M, Wang Y, Lin R, Lin T, Huang F, Fan Z, Xu Y, Yang T, Xu N, Shi P, Nie D, Lin D, Jiang Z, Wang S, Sun J, Huang X, Liu Q, Xuan L. Haploidentical transplantation has a superior graft-versus-leukemia effect than HLA-matched sibling transplantation for Ph- high-risk B-cell acute lymphoblastic leukemia. Chin Med J (Engl). 2022 Apr 20;135(8):930-939. doi: 10.1097/CM9.0000000000001852.
Results Reference
derived
PubMed Identifier
32164760
Citation
Yu S, Huang F, Fan Z, Xuan L, Nie D, Xu Y, Yang T, Wang S, Jiang Z, Xu N, Lin R, Ye J, Lin D, Sun J, Huang X, Wang Y, Liu Q. Haploidentical versus HLA-matched sibling transplantation for refractory acute leukemia undergoing sequential intensified conditioning followed by DLI: an analysis from two prospective data. J Hematol Oncol. 2020 Mar 12;13(1):18. doi: 10.1186/s13045-020-00859-5.
Results Reference
derived

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

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