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NCT Number: NCT06471478

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

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.

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Key information

Conditions

Blood Disease Hematologic Diseases Hemic and Lymphatic Diseases

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Kunming, Yunnan, 650000, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

DSA positive, receive HSCT in our hospital. -

Exclusion criteria

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

-

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. poor graft function rate

    Time frame: 2 years

    Number of patients who have >95% donor chinerism but blood morphology does not return.

  2. acute graft-versus-host disease rate

    Time frame: 2 years

    the incidence of patients who developed aGVHD

  3. chronic graft-versus-host disease rate

    Time frame: 2 years

    the incidence of patients who developed cGVHD

  4. nonrelapse mortality

    Time frame: 2 years

  5. overall survival

    Time frame: 2 years

  6. disease free survival

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hematology department of the 920th hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Jun 24, 2024
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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