LeukemiaNCT06177561
Safety and Efficacy of LPE in Clearing DSA in Patients Who Received Allo-HSCT
A study testing Lymphoplasma exchange in people with Leukemia, run by Ruijin Hospital at 1 site in China.
Trial summary
The aim of this study is to prospectively explore the effectiveness and safety of LPE in clearing DSA, and to investigate the clinical efficacy of a combination therapy with LPE in patients undergoing genetic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Lymphoplasma exchange
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2023to 8 Nov 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum DSA positive: MFI ≥ 2000；Between the ages of 18 and 65, male and female are not limited；Planned to undergo allo-HSCT , with an estimated survival time of>3 months and an ECOG physical fitness score of 0-2；Normal renal function (BUN, Cr ≤ 1.5 times the upper limit of normal value, Ccr>80ml/min)
- Normal liver function (defined as ALT and AST ≤ 1.5 times the upper limit of normal
- TBiL ≤ 1.5 times the upper limit of normal)
- ECG did not indicate any AMI, arrhythmia, or IAVB
- No CI (defined as LVEF ≥ 50%, normal MYO and BNP)
- Non active RHD
- Chest X-ray or physical examination did not indicate cardiac dilatation
- Normal lung function (defined as FEV1, FVC, DLCO ≥ 60% predicted value)
Who cannot join
- Patients with severe allergies to blood products
- The following comorbidities exist: active infection patients, active rheumatism patients
- Patients with secondary immunoglobulin deficiency
- Serious damage to important organ functions, such as respiratory failure, heart failure, decompensated liver dysfunction, renal dysfunction, etc
- Unable to obtain informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Jiaming Li, Dr, 0086-021-64370045, lijiaming007007@126.com
About this study
The aim of this study is to prospectively explore the effectiveness and safety of LPE in clearing DSA, and to investigate the clinical efficacy of a combination therapy with LPE in patients undergoing genetic hematopoietic stem cell transplantation.
Read the detailed description
We recruited 38 patients according to the inclusion criteria.(Inclusion criteria: 1. Serum DSA positive: MFI ≥ 2000；Between the ages of 18 and 65, male and female are not limited；Planned to undergo allo-HSCT , with an estimated survival time of>3 months and an ECOG physical fitness score of 0-2；Normal renal function (BUN, Cr ≤ 1.5 times the upper limit of normal value, Ccr>80ml/min). 2. Normal liver function (defined as ALT and AST ≤ 1.5 times the upper limit of normal. 3. TBiL ≤ 1.5 times the upper limit of normal). 4. ECG did not indicate any AMI, arrhythmia, or IAVB. 5. No CI (defined as LVEF ≥ 50%, normal MYO and BNP). 6. Non active RHD. 7. Chest X-ray or physical examination did not indicate cardiac dilatation. 8. Normal lung function (defined as FEV1, FVC, DLCO ≥ 60% predicted value).)
Sample the peripheral blood of the patient at four timepoints（Before LPE treatment (D0); Before stem cell transfusion; On the 10th day of stem cell transfusion;On the 30th day of stem cell transfusion).Using multiplex bead analysis on the Luminex platform (Luminex Corporation, Austin, TX, USA), including the LAB screening PRA and LAB screening hybrid method, all patients' ethylenediamine tetraacetic acid (EDTA)-treated serum was tested for anti-HLA class I and class II antibodies.According to the manufacturer's instructions, the semi-quantitative measurement of DSA levels was performed by LAB screening single antigen beads assay (One Lambda; ThermoFisher), and the results were expressed as MFI.The cumulative DSA MFI was calculated by summing the MFI of all detected DSA under HLA antigen resolution.
Evaluate the effectiveness of LPE by comparing it with the historical control group that has undergone TPE treatment in the past
- Conditions
- Leukemia
- Being tested
- Lymphoplasma exchange
- Keywords
- lymphoplasma exchange,LPE, donor specific antibody,DSA, allogeneic hematopoietic stem cell transplantation，allo-HSCT, graft failure,GF, graft-versus-host disease，GVFHD
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphoplasma exchangeProcedure or surgery
The LPE treatment regimen is: LPE*2 times (20-30ml/kg, treatment interval of 2 days);CD20 monoclonal antibody 375mg/m2*2 times, gamma globulin 0.4g/kg/d*5d.
| Study group | Role | What they receive |
|---|---|---|
| LPE group | Experimental | 1. Serum DSA positive: MFI ≥ 2000；Between the ages of 18 and 65, male and female are not limited；Planned to undergo allo-HSCT , with an estimated survival time of>3 months and an ECOG physical fitness score of 0-2；Normal renal function (BUN, Cr ≤ 1.5 times the upper limit of normal value, Ccr>80ml/min)
2. Normal liver function (defined as ALT and AST ≤ 1.5 times the upper limit of normal
3. TBiL ≤ 1.5 times the upper limit of normal)
4. ECG did not indicate any AMI, arrhythmia, or IAVB
5. No CI (defined as LVEF ≥ 50%, normal MYO and BNP)
6. Non active RHD
7. Chest X-ray or physical examination did not indicate cardiac dilatation
8. Normal lung function (defined as FEV1, FVC, DLCO ≥ 60% predicted value). Receives: Procedure: Lymphoplasma exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of decrease in DSA
A semiquantitative measurement of the DSA level was performed by LAB screen single antigen bead assays (One Lambda; Thermo Fisher) and the results were expressed as MFI
Measured: Before LPE treatment (D0); Before stem cell transfusion; On the 10th day of stem cell transfusion；On the 30th day of stem cell transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start9 Nov 2023
- Primary completion8 Nov 2024 (estimated)
- Study completion8 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoxia Hu, Dr, Principal investigator, Ruijin HospitalXuefeng Wang, Dr, Principal investigator, Ruijin HospitalZilu Zhang, Dr, Principal investigator, Ruijin HospitalXiaohong Cai, Dr, Principal investigator, Ruijin HospitalXi Wu, Dr, Principal investigator, Ruijin HospitalJialu Zhao, bachelor, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177561
- Sponsor's protocol ID
- RuijinLjm1
- Status last verified
- Nov 2023
- First submitted
- 11 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will protect the personal information of the subjects
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of LPE in Clearing DSA in Patients Who Received Allo-HSCT
- ClinicalTrials.gov ID
- NCT06177561
- Acronym / sponsor ID
- RuijinLjm1
- Conditions
- Leukemia
- Keywords
- lymphoplasma exchange,LPE, donor specific antibody,DSA, allogeneic hematopoietic stem cell transplantation，allo-HSCT, graft failure,GF, graft-versus-host disease，GVFHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 8 Nov 2024 (estimated)
- Study completion
- 8 Nov 2025 (estimated)
- First posted
- 20 Dec 2023 (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.
The aim of this study is to prospectively explore the effectiveness and safety of LPE in clearing DSA, and to investigate the clinical efficacy of a combination therapy with LPE in patients undergoing genetic hematopoietic stem cell transplantation.
Detailed description
We recruited 38 patients according to the inclusion criteria.(Inclusion criteria: 1. Serum DSA positive: MFI ≥ 2000；Between the ages of 18 and 65, male and female are not limited；Planned to undergo allo-HSCT , with an estimated survival time of>3 months and an ECOG physical fitness score of 0-2；Normal renal function (BUN, Cr ≤ 1.5 times the upper limit of normal value, Ccr>80ml/min). 2. Normal liver function (defined as ALT and AST ≤ 1.5 times the upper limit of normal. 3. TBiL ≤ 1.5 times the upper limit of normal). 4. ECG did not indicate any AMI, arrhythmia, or IAVB. 5. No CI (defined as LVEF ≥ 50%, normal MYO and BNP). 6. Non active RHD. 7. Chest X-ray or physical examination did not indicate cardiac dilatation. 8. Normal lung function (defined as FEV1, FVC, DLCO ≥ 60% predicted value).)
Sample the peripheral blood of the patient at four timepoints（Before LPE treatment (D0); Before stem cell transfusion; On the 10th day of stem cell transfusion;On the 30th day of stem cell transfusion).Using multiplex bead analysis on the Luminex platform (Luminex Corporation, Austin, TX, USA), including the LAB screening PRA and LAB screening hybrid method, all patients' ethylenediamine tetraacetic acid (EDTA)-treated serum was tested for anti-HLA class I and class II antibodies.According to the manufacturer's instructions, the semi-quantitative measurement of DSA levels was performed by LAB screening single antigen beads assay (One Lambda; ThermoFisher), and the results were expressed as MFI.The cumulative DSA MFI was calculated by summing the MFI of all detected DSA under HLA antigen resolution.
Evaluate the effectiveness of LPE by comparing it with the historical control group that has undergone TPE treatment in the past
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LPE group | Experimental | Procedure: Lymphoplasma exchange1. Serum DSA positive: MFI ≥ 2000；Between the ages of 18 and 65, male and female are not limited；Planned to undergo allo-HSCT , with an estimated survival time of>3 months and an ECOG physical fitness score of 0-2；Normal renal function (BUN, Cr ≤ 1.5 times the upper limit of normal value, Ccr>80ml/min) 2. Normal liver function (defined as ALT and AST ≤ 1.5 times the upper limit of normal 3. TBiL ≤ 1.5 times the upper limit of normal) 4. ECG did not indicate any AMI, arrhythmia, or IAVB 5. No CI (defined as LVEF ≥ 50%, normal MYO and BNP) 6. Non active RHD 7. Chest X-ray or physical examination did not indicate cardiac dilatation 8. Normal lung function (defined as FEV1, FVC, DLCO ≥ 60% predicted value). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Serum DSA positive: MFI ≥ 2000；Between the ages of 18 and 65, male and female are not limited；Planned to undergo allo-HSCT , with an estimated survival time of>3 months and an ECOG physical fitness score of 0-2；Normal renal function (BUN, Cr ≤ 1.5 times the upper limit of normal value, Ccr>80ml/min)
- Normal liver function (defined as ALT and AST ≤ 1.5 times the upper limit of normal
- TBiL ≤ 1.5 times the upper limit of normal)
- ECG did not indicate any AMI, arrhythmia, or IAVB
- No CI (defined as LVEF ≥ 50%, normal MYO and BNP)
Key exclusion criteria (5 listed)
- Patients with severe allergies to blood products
- The following comorbidities exist: active infection patients, active rheumatism patients
- Patients with secondary immunoglobulin deficiency
- Serious damage to important organ functions, such as respiratory failure, heart failure, decompensated liver dysfunction, renal dysfunction, etc
- Unable to obtain informed consent.
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 |
|---|---|---|
| Lymphoplasma exchangeThe LPE treatment regimen is: LPE*2 times (20-30ml/kg, treatment interval of 2 days);CD20 monoclonal antibody 375mg/m2*2 times, gamma globulin 0.4g/kg/d*5d. | Procedure or surgery | LPE group |
Primary outcome
The degree of decrease in DSA
Time frame: Before LPE treatment (D0); Before stem cell transfusion; On the 10th day of stem cell transfusion；On the 30th day of stem cell transfusion
A semiquantitative measurement of the DSA level was performed by LAB screen single antigen bead assays (One Lambda; Thermo Fisher) and the results were expressed as MFI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No. We will protect the personal information of the subjects
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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.
Xiaoxia Hu, Dr principal investigator
Ruijin Hospital
Xuefeng Wang, Dr principal investigator
Ruijin Hospital
Zilu Zhang, Dr principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphoplasma exchange in people with Leukemia, run by Ruijin 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?
The sponsor lists 8 inclusion and 5 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiaming Li, Dr (0086-021-64370045, lijiaming007007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of decrease in DSA (time frame: Before LPE treatment (D0); Before stem cell transfusion; On the 10th day of stem cell transfusion；On the 30th day of stem cell transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2023.