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

NCT06471478 | Completed DMC

• 2 other identifiers: KM-05202301AY070001-226
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Disease

Outcome Measures

Primary Outcomes (1)

• Graft failure Rate

  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 Outcomes (6)

• poor graft function rate

  2 years

• acute graft-versus-host disease rate

  2 years

• chronic graft-versus-host disease rate

  2 years

• nonrelapse mortality

  2 years

• overall survival

  2 years

Interventions

intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion COMBINATION_PRODUCT

patients received intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion for decresing donor specific antibodies.

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• Hematology department of the 920th hospital: lead

Study Sites (1)

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Immunoglobulins, Intravenous; Dexamethasone

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Sanbin Wang, Professor

  920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 24, 2024
• Study Start: April 1, 2019
• Primary Completion: October 30, 2021
• Study Completion: August 30, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

CN (1)