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

NCT02673008 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2020-02-25

No results posted yet for this study

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.

Conditions

  • Minimal Residual Disease
  • Donor Lymphocyte Infusion
  • Hematopoietic Stem Cell Transplantation
  • Relapse

Interventions

BIOLOGICAL

donor lymphocyte infusion

DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10\*8 mononuclear cells/kg.

Sponsors & Collaborators

  • Guangzhou First People's Hospital

    collaborator OTHER
  • Zhujiang Hospital

    collaborator OTHER
  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • Peking University People's Hospital

    collaborator OTHER
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Qifa Liu · Nanfang Hospital, Southern Medical University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-10-25
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02673008 on ClinicalTrials.gov