CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 206 enrolled
Drug / intervention
donor lymphocyte infusionbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02673008
NCT02673008Phase 3Completed

Minimal Residual Disease-directed Donor Lymphocyte Infusion for Reduce of Relapse After Allogenetic Hematopoietic Stem Cell Transplantation

Nanfang Hospital, Southern Medical University·interventional·Posted Feb 3, 2016·Updated Feb 25, 2020

In Brief

A Phase 3 clinical trial evaluating donor lymphocyte infusion for Minimal Residual Disease and 3 related conditions. Completed, enrolled 206 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 3, 2016
Enrollment StartJan 1, 2016
Primary CompletionOct 25, 2018
Study CompletionDec 31, 2019
TodayJul 1, 2026
Enrollment to primary: 2.8 yearsPosted 10.4 years ago

Interventions

donor lymphocyte infusionbiological

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