Blood DiseaseNCT06471478
The Combination of IVIG, Dexamethasone and a Megadose of PBSCs for Decreasing DSAs
An observational study of Blood Disease, run by Hematology department of the 920th hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Blood Disease
- What is being tested?
- intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who received haplo-HSCT and had donor specific antibodies at our hospital were enrolled.
Inclusion Criteria: DSA positive, receive HSCT in our hospital. -
Exclusion Criteria: Have alternative DSA-negative donor, expended life-span less than 1 month.
-
Trial locations and contacts
1 site in 1 country.
China1 site
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, 650000
About this study
Official title: 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.
Read the 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).
- Conditions
- Blood Disease
- Being tested
- intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusionCombination product
patients received intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion for decresing donor specific antibodies.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (6)
poor graft function rate
Number of patients who have >95% donor chinerism but blood morphology does not return.
Measured: 2 years
acute graft-versus-host disease rate
the incidence of patients who developed aGVHD
Measured: 2 years
chronic graft-versus-host disease rate
the incidence of patients who developed cGVHD
Measured: 2 years
nonrelapse mortality
Measured: 2 years
overall survival
Measured: 2 years
disease free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Apr 2019
- Primary completion30 Oct 2021
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hematology department of the 920th hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanbin Wang, Professor, Study director, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471478
- Sponsor's protocol ID
- KM-05
- Other IDs
- 202301AY070001-226
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li X, Li Y, Zhang D, Hu X, Liu L, Yuan Z, Li S, Dong Y, Chen Y, Wang S. The Combination of Intravenous Immunoglobulin, Dexamethasone, and a High Dose of Mononuclear Cells Transfusion: An Effective Strategy for Decreasing Donor-Specific Antibodies During Haploidentical Hematopoietic Stem Cell Transplantation. Cell Transplant. 2025 Jan-Dec;34:9636897241303292. doi: 10.1177/09636897241303292.
PubMed 39874071
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Using the Combination of IVIG, Dexamethasone and a Megadose of PBSCs Transfusion for Decreasing DSAs During Haplo-HSCT
- ClinicalTrials.gov ID
- NCT06471478
- Acronym / sponsor ID
- KM-05
- Conditions
- Blood Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hematology department of the 920th hospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received haplo-HSCT and had donor specific antibodies at our hospital were enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusionpatients received intravenous immunoglobulin, dexamethasone and a megadose of peripheral-blood stem cell transfusion for decresing donor specific antibodies. | Combination product | – |
Primary outcome
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
6 secondary outcomes
poor graft function rate
Time frame: 2 years
acute graft-versus-host disease rate
Time frame: 2 years
chronic graft-versus-host disease rate
Time frame: 2 years
nonrelapse mortality
Time frame: 2 years
overall survival
Time frame: 2 years
disease free survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Derived from this study: PubMed 39874071Li X, Li Y, Zhang D, Hu X, Liu L, Yuan Z, Li S, Dong Y, Chen Y, Wang S. The Combination of Intravenous Immunoglobulin, Dexamethasone, and a High Dose of Mononuclear Cells Transfusion: An Effective Strategy for Decreasing Donor-Specific Antibodies During Haploidentical Hematopoietic Stem Cell Transplantation. Cell Transplant. 2025 Jan-Dec;34:9636897241303292. doi: 10.1177/09636897241303292.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanbin Wang, Professor study director
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Disease, run by Hematology department of the 920th hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft failure Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06471478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.