GVHD,AcutePhase 2NCT05368181
MAP-guided Preemptive Therapy of aGvHD
A Phase 2 study testing Methylprednisolone in people with GVHD,Acute and Stem Cell Transplant Complications, run by Sichuan University at 1 site in China.
Trial summary
Acute graft versus host disease (aGvHD) is a severe and potentially fatal complication of allogeneic hematopoietic stem cell transplantation (HCT). The Mount Sinai Acute GVHD International Consortium (MAGIC) algorithm probability (MAP) identifies patients who are at high risk for severe aGvHD as early as 7 days after… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- GVHD,Acute, Stem Cell Transplant Complications
- What is being tested?
- Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Dec 2024
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any donor type (e.g., related, unrelated, haplo) or stem cell source (bone marrow, peripheral blood, cord blood).
- Any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable.
- GVHD prophylaxis must include a calcineurin inhibitor combined with post transplant cyclophosphamide.
- The use of serotherapy to prevent GVHD (e.g., antithymocyte globulin) prior to day 3 post-HCT is permitted
- Direct bilirubin must be <2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.
- ALT/SGPT and AST/SGOT must be <5 x the upper limit of the normal range within 3 days prior to enrollment.
- Signed and dated written informed consent obtained from patient or legal representative.
Who cannot join
- Patients who develop acute GVHD prior to start of study drug
- Patients at very high risk for relapse post HCT as defined by very high disease risk index
- Patients participating in a clinical trial where prevention of GVHD is the primary endpoint
- Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
- Patients who are pregnant
- Patients on dialysis within 7 days of enrollment
- Patients requiring ventilator support or oxygen supplementation exceeding 40% FiO2 within 14 days of enrollment.
- Patients receiving investigational agent within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of methylprednisolone.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Jie Ji, MD, 86-28-85422370, jieji@scu.edu.cn
About this study
Official title: The MAGIC Algorithm Probability Guided Preemption of Steroid-refractory Graft-versus-host Disease With Methylprednisolone
Acute graft versus host disease (aGvHD) is a severe and potentially fatal complication of allogeneic hematopoietic stem cell transplantation (HCT). The Mount Sinai Acute GVHD International Consortium (MAGIC) algorithm probability (MAP) identifies patients who are at high risk for severe aGvHD as early as 7 days after HCT based on 2 serum biomarkers, suppressor of tumorigenesis 2 (ST2) and regenerating islet-derived 3α (Reg3α). Patients who consent to this study will have their blood tested weekly up to four times within the first month post HCT to determine if they are at high risk for severe GVHD based on MAP. Patients who are at high risk at any of these four tests will be treated with methylprednisolone to see if it prevents the development of severe aGvHD. Methylprednisolone starts with the dose of 2 mg/kg for 5 days. If no signs of aGvHD, the dose of methylprednisolone is gradually tapered within the following 16 days. Patients will be followed for the development of severe aGvHD for up to 3 months from the HCT and will continue to be followed at routine clinic visits for up to one year after HCT.
- Conditions
- GVHD,Acute, Stem Cell Transplant Complications
- Being tested
- Methylprednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone starts with the dose of 2 mg/kg for 5 days. If no signs of aGvHD, the dose of methylprednisolone is gradually taper with the following 16 days.
| Study group | Role | What they receive |
|---|---|---|
| Prevention group | Experimental | Methylprednisolone starts with the dose of 2 mg/kg for 5 days. If no signs of aGvHD, the dose of methylprednisolone is gradually taper with the following 16 days. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of High Risk Patients Who Develop Grade III or IV aGvHD
Number of High Risk Patients Who Develop Grade III or IV aGvHD by day 100 post HCT
Measured: Day 100 post HCT
Secondary outcomes (8)
Number of Participants Alive at 6 Months and 1 Year
Overall survival - The number of that patients are still alive from the start of treatment at 6 months and 1 year
Measured: 6 months and 1 year
Number of Participants With Non-relapse Mortality (NRM)
Number of participants with NRM - deaths which could not be attributed to disease relapse or progression. Non-relapse mortality defined as death without prior relapse.
Measured: 6 months and 1 year
Number of Participants With Relapse
Number of participants with relapse at one year. Relapse defined as recurrence of disease that required transplant.
Measured: 1 year
Number of Participants With Clinically Relevant GVHD States Grade II-IV GVHD
Number of participants with clinically relevant GVHD states grade II-IV GVHD requiring systemic treatment.
Measured: 100 days
Number of Participants With Chronic GVHD Requiring Systemic Steroid Treatment
Number of participants with chronic GVHD requiring systemic steroid treatment. Chronic GVHD Requiring Systemic Steroid Treatment: defined as the development of symptoms of chronic GVHD according to NIH Consensus Criteria that require treatment with oral or intravenous corticosteroids.
Measured: 1 year
Number of Participants With Serious Infections
Number of participants with serious infections (defined as grade 3 by the Blood and Marrow Transplant Clinical Trials Network). Serious Infection: Defined as bacterial, fungal, viral or parasitic infections that required oral or intravenous treatments such as antibiotics.
Measured: 1 year
Overall survival
Overall survival of this group of patients at the end of 1 year
Measured: 1 year
GvHD free and relapse free survival
Survival of patients without grade 3 or 4 aGvHD or disseminated cGvHD or relapse of disease at end of 1 year post HCT
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 posted10 May 2022
- Study start1 May 2022
- Primary completion30 Jan 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHD,AcuteStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- methylprednisolone
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Ji, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368181
- Sponsor's protocol ID
- HXMAP 1.0
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 10 May 2022
- 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 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MAGIC Algorithm Probability Guided Preemption of Steroid-refractory Graft-versus-host Disease With Methylprednisolone
- ClinicalTrials.gov ID
- NCT05368181
- Acronym / sponsor ID
- HXMAP 1.0
- Conditions
- GVHD,Acute, Stem Cell Transplant Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 May 2022 (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.
Acute graft versus host disease (aGvHD) is a severe and potentially fatal complication of allogeneic hematopoietic stem cell transplantation (HCT). The Mount Sinai Acute GVHD International Consortium (MAGIC) algorithm probability (MAP) identifies patients who are at high risk for severe aGvHD as early as 7 days after HCT based on 2 serum biomarkers, suppressor of tumorigenesis 2 (ST2) and regenerating islet-derived 3α (Reg3α). Patients who consent to this study will have their blood tested weekly up to four times within the first month post HCT to determine if they are at high risk for severe GVHD based on MAP. Patients who are at high risk at any of these four tests will be treated with methylprednisolone to see if it prevents the development of severe aGvHD. Methylprednisolone starts with the dose of 2 mg/kg for 5 days. If no signs of aGvHD, the dose of methylprednisolone is gradually tapered within the following 16 days. Patients will be followed for the development of severe aGvHD for up to 3 months from the HCT and will continue to be followed at routine clinic visits for up to one year after HCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- methylprednisolone
| Arm | Type | Receives |
|---|---|---|
| Prevention group | Experimental | Drug: MethylprednisoloneMethylprednisolone starts with the dose of 2 mg/kg for 5 days. If no signs of aGvHD, the dose of methylprednisolone is gradually taper with the following 16 days. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Any donor type (e.g., related, unrelated, haplo) or stem cell source (bone marrow, peripheral blood, cord blood).
- Any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable.
- GVHD prophylaxis must include a calcineurin inhibitor combined with post transplant cyclophosphamide.
- The use of serotherapy to prevent GVHD (e.g., antithymocyte globulin) prior to day 3 post-HCT is permitted
- Direct bilirubin must be <2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.
Key exclusion criteria (8 listed)
- Patients who develop acute GVHD prior to start of study drug
- Patients at very high risk for relapse post HCT as defined by very high disease risk index
- Patients participating in a clinical trial where prevention of GVHD is the primary endpoint
- Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
- Patients who are pregnant
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 |
|---|---|---|
| MethylprednisoloneMethylprednisolone starts with the dose of 2 mg/kg for 5 days. If no signs of aGvHD, the dose of methylprednisolone is gradually taper with the following 16 days. | Drug | Prevention group |
Primary outcome
Number of High Risk Patients Who Develop Grade III or IV aGvHD
Time frame: Day 100 post HCT
Number of High Risk Patients Who Develop Grade III or IV aGvHD by day 100 post HCT
8 secondary outcomes
Number of Participants Alive at 6 Months and 1 Year
Time frame: 6 months and 1 year
Number of Participants With Non-relapse Mortality (NRM)
Time frame: 6 months and 1 year
Number of Participants With Relapse
Time frame: 1 year
Number of Participants With Clinically Relevant GVHD States Grade II-IV GVHD
Time frame: 100 days
Number of Participants With Chronic GVHD Requiring Systemic Steroid Treatment
Time frame: 1 year
Number of Participants With Serious Infections
Time frame: 1 year
Overall survival
Time frame: 1 year
GvHD free and relapse free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- 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. This study is not recruiting at the moment.
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 Methylprednisolone in people with GVHD,Acute and Stem Cell Transplant Complications, run by Sichuan University 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 7 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: status not confirmed, as of the sponsor's last update on 10 May 2022. 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 Jie Ji, MD (86-28-85422373, jieji@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of High Risk Patients Who Develop Grade III or IV aGvHD (time frame: Day 100 post HCT). 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 10 May 2022.