Acute Graft Versus Host DiseasePhase 2NCT06480630
Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases
A Phase 2 study testing Basiliximab in people with Acute Graft Versus Host Disease and Malignant Hematologic Neoplasm, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Evaluating the safety and effectiveness of a CD25 monoclonal antibody-based prophylactic acute graft-versus-host-disease (aGVHD) regimen following unrelated umbilical cord blood transplantation (UCBT) for malignant hematologic disorders in reducing severe aGVHD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Graft Versus Host Disease, Malignant Hematologic Neoplasm
- What is being tested?
- Basiliximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Malignant hematologic disorders;
- Patients undergoing UCBT;
- Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during treatment and for the following year.
Who cannot join
- Non-malignant hematologic disorders;
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Uncontrolled bacterial, viral, or fungal infections. "Uncontrolled" is defined as lack of clinical improvement or progression despite adequate antimicrobial therapy;
- HIV infection or active hepatitis B or C virus infection;
- Pregnant or lactating women;
- Substance abusers; subjects with uncontrolled psychiatric disorders; individuals with cognitive dysfunction;
- Participation in similar clinical studies within the past 3 months;
- Subjects deemed unsuitable by the investigator (e.g., those expected to be unable to adhere to treatment due to financial constraints).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei
Xiaoyu Zhu, Ph.D, 15255456091, xiaoyuz@ustc.cn
Kaidi Song, M.D, 18715062778, kaidisong@163.com
About this study
Evaluating the safety and effectiveness of a CD25 monoclonal antibody-based prophylactic acute graft-versus-host-disease (aGVHD) regimen following unrelated umbilical cord blood transplantation (UCBT) for malignant hematologic disorders in reducing severe aGVHD.
Read the detailed description
Acute graft-versus-host disease (aGVHD) is a major complication and leading cause of non-relapse mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Preliminary research findings suggest that the addition of CD25 monoclonal antibody at +3 days post unrelated umbilical cord blood transplantation (UCBT) has reduced the incidence of grade III-IV aGVHD compared to previous protocols. In order to further explore how to improve prevention strategies of aGVHD and reduce the incidence of severe aGVHD, we performed this study to evaluate the safety and effectiveness of a prophylactic GVHD regimen utilizing CD25 monoclonal antibody post-UCBT for malignant hematologic disorders, aimed at reducing the incidence of severe aGVHD.
- Being tested
- Basiliximab
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasiliximabDrug
Addition of CD25 monoclonal antibody（Basiliximab） at +3 days post unrelated umbilical cord blood transplantation (UCBT)
| Study group | Role | What they receive |
|---|---|---|
| basiliximab group | Experimental | Not described Receives: Drug: Basiliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD)
The primary endpoint of the study will be the development of aGVHD in the first 100 days post-transplant. Acute GVHD was graded according to the International Consortium criteria.
Measured: within 100 days post-UCBT
Secondary outcomes (10)
The incidence rate and occurrence time of pre-engraftment syndrome (PES)
The occurrence time and cumulative incidence of PES within 30 days post-UCBT. The PES was diagnosed according to the criteria of engraftment syndrome (ES) .
Measured: within 30 days post-UCBT
The cumulative incidence of neutrophil engraftment at 28 days after transplantation
Neutrophil engraftment time was defined as the first of three consecutive days during which the neutrophil count was at least 0.5×10^9/L.
Measured: within 28 days post-UCBT
The cumulative incidence of platelet engraftment at 100 days after transplantation
Platelet engraftment is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥ 20 × 10^9/L.
Measured: within 100 days post-UCBT
The incidence of grade II to IV aGVHD
The cumulative incidence of grade II to IV aGVHD in the first 100 days post-transplant. aGVHD was graded according to the aGVHD International Consortium criteria.
Measured: within 100 days post-UCBT
The cumulative incidence of chronic GVHD at 360 days after transplantation
The severity of chronic GVHD was graded according to the 2014 NIH criteria.
Measured: 360 days
The cumulative incidence of transplant-related mortality at 180 days after transplantation
The cumulative incidence of transplant-related mortality at 180 days after transplantation.
Measured: 180 days
The cumulative incidence of relapse
The cumulative incidence of relapse at 1 year after transplantation.
Measured: 1 year
The probability of disease-free survival(DFS)
The DFS was defined as the interval between transplantation and disease recurrence, death or the last follow-up date, whichever occurred first.
Measured: 1 year
The probability of overall survival(OS)
The OS was determined to be the time from the first day of transplantation until death from any cause or the last follow-up date.
Measured: 1 year
The probability of GVHD-free, relapse-free survival(GRFS)
The composite endpoint of GRFS was defined as the first events occurring after transplantation among Grade III to IV aGVHD, moderate to severe cGVHD, relapse, or death for any reason.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Addition of CD25 monoclonal antibody at +3 days post unrelated umbilical cord blood transplantation (UCBT)
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xiaoyu Zhu, Ph.D, Principal investigator, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480630
- Sponsor's protocol ID
- CD25-2024
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases
- ClinicalTrials.gov ID
- NCT06480630
- Acronym / sponsor ID
- CD25-2024
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 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.
Evaluating the safety and effectiveness of a CD25 monoclonal antibody-based prophylactic acute graft-versus-host-disease (aGVHD) regimen following unrelated umbilical cord blood transplantation (UCBT) for malignant hematologic disorders in reducing severe aGVHD.
Detailed description
Acute graft-versus-host disease (aGVHD) is a major complication and leading cause of non-relapse mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Preliminary research findings suggest that the addition of CD25 monoclonal antibody at +3 days post unrelated umbilical cord blood transplantation (UCBT) has reduced the incidence of grade III-IV aGVHD compared to previous protocols. In order to further explore how to improve prevention strategies of aGVHD and reduce the incidence of severe aGVHD, we performed this study to evaluate the safety and effectiveness of a prophylactic GVHD regimen utilizing CD25 monoclonal antibody post-UCBT for malignant hematologic disorders, aimed at reducing the incidence of severe aGVHD.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Addition of CD25 monoclonal antibody at +3 days post unrelated umbilical cord blood transplantation (UCBT)
| Arm | Type | Receives |
|---|---|---|
| basiliximab group | Experimental | Drug: Basiliximab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Malignant hematologic disorders;
- Patients undergoing UCBT;
- Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during treatment and for the following year.
Key exclusion criteria (8 listed)
- Non-malignant hematologic disorders;
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Uncontrolled bacterial, viral, or fungal infections. "Uncontrolled" is defined as lack of clinical improvement or progression despite adequate antimicrobial therapy;
- HIV infection or active hepatitis B or C virus infection;
- Pregnant or lactating women;
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 |
|---|---|---|
| BasiliximabAddition of CD25 monoclonal antibody（Basiliximab） at +3 days post unrelated umbilical cord blood transplantation (UCBT) | Drug | basiliximab group |
Primary outcome
The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD)
Time frame: within 100 days post-UCBT
The primary endpoint of the study will be the development of aGVHD in the first 100 days post-transplant. Acute GVHD was graded according to the International Consortium criteria.
10 secondary outcomes
The incidence rate and occurrence time of pre-engraftment syndrome (PES)
Time frame: within 30 days post-UCBT
The cumulative incidence of neutrophil engraftment at 28 days after transplantation
Time frame: within 28 days post-UCBT
The cumulative incidence of platelet engraftment at 100 days after transplantation
Time frame: within 100 days post-UCBT
The incidence of grade II to IV aGVHD
Time frame: within 100 days post-UCBT
The cumulative incidence of chronic GVHD at 360 days after transplantation
Time frame: 360 days
The cumulative incidence of transplant-related mortality at 180 days after transplantation
Time frame: 180 days
The cumulative incidence of relapse
Time frame: 1 year
The probability of disease-free survival(DFS)
Time frame: 1 year
The probability of overall survival(OS)
Time frame: 1 year
The probability of GVHD-free, relapse-free survival(GRFS)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Xiaoyu Zhu, Ph.D principal investigator
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
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 Basiliximab in people with Acute Graft Versus Host Disease and Malignant Hematologic Neoplasm, run by Anhui Provincial 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Zhu, Ph.D (15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD) (time frame: within 100 days post-UCBT). 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 Jun 2024.