aGVHDPhase 1/2IvarmacitinibNCT07381114
A Clinical Study on the Efficacy and Safety of Ivarmacitinib in Preventing aGVHD After HLA-matched Transplantation
A Phase 1/2 study testing Ivarmacitinib in people with aGVHD, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
To apply Ivarmacitinib for the prevention of acute graft-versus-host disease (aGVHD) in HLA haploidentical transplantation, the incidence of grade II-IV aGVHD after prevention, the incidence of primary graft failure, the rate of GVHD-free relapse-free survival (GRFS) (12 months), the incidence of infection, the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- aGVHD
- What is being tested?
- Ivarmacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 14 Feb 2026to 30 Dec 2027
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients have been clearly diagnosed with hematological malignancies, including acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. The planned treatment for these patients is myeloablative or reduced-intensity conditioning, followed by HLA half-matched stem cell transplantation.
- Has not received any systemic treatment, including extracorporeal photodynamic therapy (ECP)
- KPS>60% or ECOG PS 0-2
- Patients who have not received any other prophylactic immunosuppressive agents or aGVHD/cGVHD treatment are eligible
- The female subjects of childbearing age are willing to use a medically approved highly effective contraceptive method (such as intrauterine device, contraceptive pill or condom) during the study period and within 180 days after the last administration of the study drug; for male subjects whose partners are of childbearing age, they agree to use an effective contraceptive method during the study period and within 180 days after the last administration of the study drug
Who cannot join
- Pregnant women or women who are breastfeeding
- Absolute Neutrophil Count (ANC) < 1.0 x 109/L or Platelet Count < 50 x 109/L
- Uncontrolled active infections or active hepatitis B or hepatitis that requires antiviral treatment
- Human Immunodeficiency Virus (HIV) positive
- Uncontrolled concurrent diseases, including but not limited to persistent or active infections, autoimmune diseases, thrombosis, symptomatic congestive heart failure, unstable angina pectoris, unstable arrhythmias, or mental disorders/situations that would limit compliance with the study requirements
- There are severe respiratory system diseases, severe renal function impairment, clinically significant or uncontrolled heart diseases, unresolved cholestasis and liver diseases (not attributable to aGvHD). Diseases that interfere with coagulation or platelet function and/or current drug treatments
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- Immunosuppressive doses of steroids. This does not exclude the use of steroids in subjects with adrenal cortical insufficiency
- The diagnosis was clear: chronic lymphocytic leukemia, marginal zone lymphoma (MALT type), smoldering multiple myeloma, etc., all being low-grade malignant/cancer-preventing blood tumors
- Patients who have been diagnosed with pre-transplantation digestive tract perforation and have a history of gastric or intestinal resection surgeries, etc., may have their drug absorption affected
- It is known that there may be allergic reactions, hypersensitivity reactions or intolerance to the studied drug or its excipients
- The researchers believe that there are any conditions that might harm the subjects or prevent them from fulfilling or meeting the requirements of the study
About this study
Official title: Phase II Clinical Study on the Efficacy and Safety of Ivarmacitinib in Preventing Acute Graft-versus-host Disease After HLA-matched Transplantation
To apply Ivarmacitinib for the prevention of acute graft-versus-host disease (aGVHD) in HLA haploidentical transplantation, the incidence of grade II-IV aGVHD after prevention, the incidence of primary graft failure, the rate of GVHD-free relapse-free survival (GRFS) (12 months), the incidence of infection, the incidence of chronic graft-versus-host disease (cGvHD) (100 days - 1 year), treatment-related mortality, the incidence and severity of cytokine release syndrome (CRS), and the safety of the prevention regimen will be evaluated.
Read the detailed description
This project is a prospective, single-arm clinical study. It aims to apply Ivarmacitinib for the prevention of acute graft-versus-host disease (aGVHD) in patients with hematological malignancies undergoing HLA-mismatched transplantation. The primary objective is to observe the incidence of grade II-IV aGVHD after transplantation prevention. The secondary objectives include the incidence of primary graft failure, graft-versus-host disease-free and relapse-free survival (GRFS) at 12 months, the incidence of infection, the incidence of chronic graft-versus-host disease (cGvHD) within 100 days to 1 year, treatment-related mortality, the incidence and severity of cytokine release syndrome (CRS), and the safety assessment of the prevention regimen. This study is intended to provide a reference for the clinical application of Ivarmacitinib in transplantation. Therefore, this research is proposed to be conducted.
- Conditions
- aGVHD
- Being tested
- Ivarmacitinib
- Keywords
- Ivarmacitinib, aGVHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvarmacitinibDrug
Patients at the RP2D dose during the dose exploration phase were enrolled in the expansion study. Patients in the expansion study received RP2D Ivarmacitinib treatment daily for 3 days to 100 days.
| Study group | Role | What they receive |
|---|---|---|
| Ivarmacitinib | Experimental | During the dose exploration phase, the "3+3" method was used for Ivarmacitinib, with the dose incrementing from 2mg to 6mg. The medication was administered starting from -3 days and observation continued until 28 days after transplantation to determine the RP2D dose. Patients at the RP2D dose during the dose exploration phase were enrolled in the expansion study. Patients in the expansion study received RP2D Ivarmacitinib treatment daily for 3 days to 100 days. Receives: Drug: Ivarmacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of grade II-IV aGVHD
Measured: up to 2 years
Secondary outcomes (2)
the incidence of primary graft failure
Measured: up to 2 years
the event-free survival (GRFS) without GVHD (12 months)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start14 Feb 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for aGVHDStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381114
- Sponsor's protocol ID
- IIT2025130
- Acronym
- Ivarmacitinib
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study on the Efficacy and Safety of Ivarmacitinib in Preventing Acute Graft-versus-host Disease After HLA-matched Transplantation
- ClinicalTrials.gov ID
- NCT07381114
- Acronym / sponsor ID
- Ivarmacitinib / IIT2025130
- Conditions
- aGVHD
- Keywords
- Ivarmacitinib, aGVHD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 14 Feb 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Feb 2026 (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.
To apply Ivarmacitinib for the prevention of acute graft-versus-host disease (aGVHD) in HLA haploidentical transplantation, the incidence of grade II-IV aGVHD after prevention, the incidence of primary graft failure, the rate of GVHD-free relapse-free survival (GRFS) (12 months), the incidence of infection, the incidence of chronic graft-versus-host disease (cGvHD) (100 days - 1 year), treatment-related mortality, the incidence and severity of cytokine release syndrome (CRS), and the safety of the prevention regimen will be evaluated.
Detailed description
This project is a prospective, single-arm clinical study. It aims to apply Ivarmacitinib for the prevention of acute graft-versus-host disease (aGVHD) in patients with hematological malignancies undergoing HLA-mismatched transplantation. The primary objective is to observe the incidence of grade II-IV aGVHD after transplantation prevention. The secondary objectives include the incidence of primary graft failure, graft-versus-host disease-free and relapse-free survival (GRFS) at 12 months, the incidence of infection, the incidence of chronic graft-versus-host disease (cGvHD) within 100 days to 1 year, treatment-related mortality, the incidence and severity of cytokine release syndrome (CRS), and the safety assessment of the prevention regimen. This study is intended to provide a reference for the clinical application of Ivarmacitinib in transplantation. Therefore, this research is proposed to be conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivarmacitinib | Experimental | Drug: IvarmacitinibDuring the dose exploration phase, the "3+3" method was used for Ivarmacitinib, with the dose incrementing from 2mg to 6mg. The medication was administered starting from -3 days and observation continued until 28 days after transplantation to determine the RP2D dose. Patients at the RP2D dose during the dose exploration phase were enrolled in the expansion study. Patients in the expansion study received RP2D Ivarmacitinib treatment daily for 3 days to 100 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patients have been clearly diagnosed with hematological malignancies, including acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. The planned treatment for these patients is myeloablative or reduced-intensity conditioning, followed by HLA half-matched stem cell transplantation.
- Has not received any systemic treatment, including extracorporeal photodynamic therapy (ECP)
- KPS>60% or ECOG PS 0-2
- Patients who have not received any other prophylactic immunosuppressive agents or aGVHD/cGVHD treatment are eligible
- The female subjects of childbearing age are willing to use a medically approved highly effective contraceptive method (such as intrauterine device, contraceptive pill or condom) during the study period and within 180 days after the last administration of the study drug; for male subjects whose partners are of childbearing age, they agree to use an effective contraceptive method during the study period and within 180 days after the last administration of the study drug
Key exclusion criteria (11 listed)
- Pregnant women or women who are breastfeeding
- Absolute Neutrophil Count (ANC) < 1.0 x 109/L or Platelet Count < 50 x 109/L
- Uncontrolled active infections or active hepatitis B or hepatitis that requires antiviral treatment
- Human Immunodeficiency Virus (HIV) positive
- Uncontrolled concurrent diseases, including but not limited to persistent or active infections, autoimmune diseases, thrombosis, symptomatic congestive heart failure, unstable angina pectoris, unstable arrhythmias, or mental disorders/situations that would limit compliance with the study requirements
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 |
|---|---|---|
| IvarmacitinibPatients at the RP2D dose during the dose exploration phase were enrolled in the expansion study. Patients in the expansion study received RP2D Ivarmacitinib treatment daily for 3 days to 100 days. | Drug | Ivarmacitinib |
Primary outcome
incidence of grade II-IV aGVHD
Time frame: up to 2 years
2 secondary outcomes
the incidence of primary graft failure
Time frame: up to 2 years
the event-free survival (GRFS) without GVHD (12 months)
Time frame: 12 months
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 2 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ivarmacitinib in people with aGVHD, run by Institute of Hematology & Blood Diseases Hospital, 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 5 inclusion and 11 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 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
incidence of grade II-IV aGVHD (time frame: up to 2 years). 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 2 Feb 2026.