Clinical trial NCT06471478: The Combination of IVIG, Dexamethasone and a Megadose of PBSCs for Decreasing DSAs
Official title: A Retrospective Study Using the Combination of IVIG, Dexamethasone and a Megadose of PBSCs Transfusion for Decreasing DSAs During Haplo-HSCT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Disease
Lead sponsor: Hematology department of the 920th hospital
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 11
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received haplo-HSCT and had donor specific antibodies at our hospital were enrolled.

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.

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).

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

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

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Primary outcomes:
measure: Graft failure Rate
timeFrame: 2 years
Secondary outcomes:
measure: poor graft function rate
timeFrame: 2 years
measure: acute graft-versus-host disease rate
timeFrame: 2 years
measure: chronic graft-versus-host disease rate
timeFrame: 2 years
measure: nonrelapse mortality
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
measure: disease free survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Kunming
country: China
facility: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
state: Yunnan
Study officials:
affiliation: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
name: Sanbin Wang, Professor
role: STUDY_DIRECTOR
References: