GVHDPhase 2NCT06334367
Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT
A Phase 2 study testing CD25 treatment and low-dose ATG in people with GVHD, run by Wang Xin at 1 site in China.
Trial summary
The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- GVHD
- What is being tested?
- CD25 treatment and low-dose ATG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2024to 26 Mar 2026
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a clear diagnosis of hematologic disease, weighing ≥30kg, aged 18-60, of any gender and race;
- Willing to undergo haploidentical hematopoietic stem cell transplantation;
- Voluntarily participate in this study;
- Each subject must sign an informed consent form (ICF) indicating their understanding of the purpose and procedures of the study, and their willingness to participate. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member.
Who cannot join
- Those with severe organ dysfunction or diseases, such as heart, liver, kidney, and pancreatic diseases;
- Patients who cannot tolerate CD25 monoclonal antibody treatment;
- Subjects and/or authorized family members who refuse allo-HSCT treatment;
- Any life-threatening diseases, physical conditions, or organ system dysfunctions that the researcher believes may jeopardize the safety of the subject and pose unnecessary risks to the study; drug dependence; uncontrolled mental illness in subjects; cognitive dysfunction;
- Those who have participated in other similar clinical studies within the past 3 months;
- Those deemed unsuitable for inclusion by the researcher (such as patients expected to be unable to adhere to treatment due to financial issues, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021
Xin Wang, MD, PHD, 86-531-68778331, xinw007@126.com
Xiaosheng Fang, MD, PHD, 8615168889703, fxsh_1010@126.com
About this study
Official title: The Study of Anti-CD25 Antibody for Prophylaxis of GVHD in Patients Underwent Haploid Transplantation Conditioning With Low-dose ATG
The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition.
- Conditions
- GVHD
- Being tested
- CD25 treatment, low-dose ATG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD25 treatmentDrug
CD25 prophylaxis
low-dose ATGDrug
HSCT pre-treatment with 7.5mg/Kg ATG(2.5mg/Kg/d) at day -4, -3 and -2.
| Study group | Role | What they receive |
|---|---|---|
| CD25 treatment | Experimental | The humanized CD25 antibody was administered at 1 mg/kg iv on days+4 and +7 after HSCT. Receives: Drug: CD25 treatment; Drug: low-dose ATG |
| control group | Other | Not described Receives: Drug: low-dose ATG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of aGVHD
The time of aGVHD occurrence
Measured: 100 days after HSCT
The incidence of cGVHD
The time of cGVHD occurrence
Measured: 1 year after HSCT
Secondary outcomes (5)
the time of immune reconstitution in haploidentical transplant
the time of immune reconstitution in haploidentical transplant
Measured: 2 years after HSCT
the time of infection occurrence
The incidence of infection
Measured: 2 years after HSCT
the time of donor cell engraftment
the effect of experimental protocol to engraftment
Measured: 2 years after HSCT
the time of disease relapse
the effect of experimental protocol to disease relapse
Measured: 2 years after HSCT
the time of death of transplant patient
the overall survival of patients
Measured: 2 years after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start26 Mar 2024 (estimated)
- Primary completion26 Mar 2026 (estimated)
- Study completion26 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHDStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Xin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Wang Xin, Shandong Provincial Hospital
- Investigators
- Xin Wang, Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334367
- Sponsor's protocol ID
- SWYX:NO.2022-1028
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We need to collect data during the experiment for a more comprehensive sharing.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Anti-CD25 Antibody for Prophylaxis of GVHD in Patients Underwent Haploid Transplantation Conditioning With Low-dose ATG
- ClinicalTrials.gov ID
- NCT06334367
- Acronym / sponsor ID
- SWYX:NO.2022-1028
- Conditions
- GVHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wang XinOther government
- Study start
- 26 Mar 2024 (estimated)
- Primary completion
- 26 Mar 2026 (estimated)
- Study completion
- 26 Mar 2026 (estimated)
- First posted
- 28 Mar 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.
The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD25 treatment | Experimental | Drug: CD25 treatment, Drug: low-dose ATGThe humanized CD25 antibody was administered at 1 mg/kg iv on days+4 and +7 after HSCT. |
| control group | Other | Drug: low-dose ATG |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with a clear diagnosis of hematologic disease, weighing ≥30kg, aged 18-60, of any gender and race;
- Willing to undergo haploidentical hematopoietic stem cell transplantation;
- Voluntarily participate in this study;
- Each subject must sign an informed consent form (ICF) indicating their understanding of the purpose and procedures of the study, and their willingness to participate. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member.
Key exclusion criteria (6 listed)
- Those with severe organ dysfunction or diseases, such as heart, liver, kidney, and pancreatic diseases;
- Patients who cannot tolerate CD25 monoclonal antibody treatment;
- Subjects and/or authorized family members who refuse allo-HSCT treatment;
- Any life-threatening diseases, physical conditions, or organ system dysfunctions that the researcher believes may jeopardize the safety of the subject and pose unnecessary risks to the study; drug dependence; uncontrolled mental illness in subjects; cognitive dysfunction;
- Those who have participated in other similar clinical studies within the past 3 months;
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 |
|---|---|---|
| CD25 treatmentCD25 prophylaxis | Drug | CD25 treatment |
| low-dose ATGHSCT pre-treatment with 7.5mg/Kg ATG(2.5mg/Kg/d) at day -4, -3 and -2. | Drug | CD25 treatment, control group |
Primary outcome
The incidence of aGVHD
Time frame: 100 days after HSCT
The time of aGVHD occurrence
The incidence of cGVHD
Time frame: 1 year after HSCT
The time of cGVHD occurrence
5 secondary outcomes
the time of immune reconstitution in haploidentical transplant
Time frame: 2 years after HSCT
the time of infection occurrence
Time frame: 2 years after HSCT
the time of donor cell engraftment
Time frame: 2 years after HSCT
the time of disease relapse
Time frame: 2 years after HSCT
the time of death of transplant patient
Time frame: 2 years after HSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No. We need to collect data during the experiment for a more comprehensive sharing.
Related trials for GVHD
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De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
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HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
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Graft-Versus-Host Disease, Graft-versus-leukemia
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The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
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.
Xin Wang study chair
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD25 treatment and low-dose ATG in people with GVHD, run by Wang Xin 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 4 inclusion and 6 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 28 Mar 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaosheng Fang (8615168889703 ext. 8615168889703, fxsh_1010@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of aGVHD (time frame: 100 days after HSCT). The study lists 2 primary outcomes in all. 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 28 Mar 2024.