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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HMA+DLI vs DLI Preemptive Therapy Based on MRD for AL Undergoing Allo-HSCT

NCT03662087

Minimal Residual Disease,Acute Leukemia, Hypomethylating Agents, Donor Lymphocyte Infusion, Allogeneic Hematopoietic Cell Transplantation

UNKNOWN PHASE2/PHASE3

Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant

NCT03297528

Donor Lymphocyte Infusion Allogeneic Hematopoietic Stem Cell Transplantation Acute Leukemia +3 more

UNKNOWN PHASE2

Pre-DLI or Pro-DLI in Relapsed/Refractory Myeloid Neoplasms After HSCT

NCT07319793

Acute Myeloid Leukemia Myelodysplastic Syndromes (MDS)

NOT_YET_RECRUITING NA

MRD-directed Therapy for Low-risk and Intermediate-risk AML.

NCT02870777

Acute Myeloid Leukemia Minimal Residual Disease

COMPLETED PHASE2/PHASE3

Safety and Efficacy of Allogenic NK Cells in Combination With Chemotherapy in the Treatment of r/r AML After Allo-HSCT

NCT05744440

Acute Myeloid Leukemia

UNKNOWN EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Minimal Residual Disease Donor Lymphocyte Infusion Hematopoietic Stem Cell Transplantation Relapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

donor lymphocyte infusion

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

donor lymphocyte infusion

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No