The Combination of IVIG, Dexamethasone and a Megadose of PBSCs for Decreasing DSAs

June 18, 2024 updated by: Hematology department of the 920th hospital

A Retrospective Study Using the Combination of IVIG, Dexamethasone and a Megadose of PBSCs Transfusion for Decreasing DSAs During Haplo-HSCT

Donor-specific antibodies (DSAs) are essential causes of graft rejection in haploidentical hematopoietic stem cell transplantation (haplo-HSCT). DSAs are unavoidable for some patients who have no alternative donor. Effective interventions to reduce DSAs are still needed, and the cost of the current therapies is relatively high. Investigators wanted to retrospectively analyzed the data of 11 DSA-positive participants who received haplo-HSCT at our center and evaluated the therapeutic efficacy of the combination of intravenous immunoglobulin (IVIG), dexamethasone and megadose of transfused peripheral blood stem cells (PBSCs) for DSA desensitization.

Study Overview

Status

Completed

Conditions

Blood Disease

Intervention / Treatment

Combination product: intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion

Detailed Description

Investigators retrospectively analyzed the data of 11 DSA-positive participants who received haplo-HSCT at our center. All patients received 1 g/kg IVIG on day -1 and 25 mg/m2/d dexamethasone on days -4~-1 before transplantation, and approximately three doses of PBSCs were transfused. On the basis of the conventional transfusion amount of hematopoietic stem cells, additional PBSCs were transfused based on the DSA level of each patient: 3±2×108/kg, 6±2×108/kg and 9±2×108/kg mononuclear cells for participants whose DSAs were weakly positive, positive and strongly positive, respectively.

Blood samples from participants were collected at the following 5 time points: before HSCT and +1 day, +8 day, +15 day and +22 day after transplantation.

The primary endpoint was the incidence of PGF. The secondary endpoints were the incidence of poor graft function, acute and chronic GVHD, relapse, nonrelapse mortality (NRM), overall survival (OS) and disease-free survival (DFS).

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Yunnan
  - Kunming, Yunnan, China, 650000
    - 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients who received haplo-HSCT and had donor specific antibodies at our hospital were enrolled.

Description

Inclusion Criteria: DSA positive, receive HSCT in our hospital. -

Exclusion Criteria: Have alternative DSA-negative donor, expended life-span less than 1 month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft failure Rate Time Frame: 2 years	Number of patients who did not have graft engraftment. Graft failure was defined as the return of recipient hematopoiesis as confirmed by chemerism analysis as <%% donor chimerism at +28 day after HSCT	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival Time Frame: 2 years		2 years
disease free survival Time Frame: 2 years		2 years
poor graft function rate Time Frame: 2 years	Number of patients who have >95% donor chinerism but blood morphology does not return.	2 years
acute graft-versus-host disease rate Time Frame: 2 years	the incidence of patients who developed aGVHD	2 years
chronic graft-versus-host disease rate Time Frame: 2 years	the incidence of patients who developed cGVHD	2 years
nonrelapse mortality Time Frame: 2 years		2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hematology department of the 920th hospital

Investigators

Study Director: Sanbin Wang, Professor, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)