Graft Versus Host DiseaseNCT04838704
Ruxolitinib With Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation
A study testing Ruxolitinib+Calcineurin inhibitor+Methotrexate and Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil in people with Graft Versus Host Disease, run by Zhejiang University at 1 site in China.
Trial summary
Low Dose Ruxolitinib with Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor plus Methotrexate and Mycophenolate mofetil as Graft Versus Host Disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- Ruxolitinib+Calcineurin inhibitor+Methotrexate and Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 Dec 2024
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be diagnosed with malignant hematological disease.
- aged 12-70 years.
- Received HLA-haploidentical hematopoietic stem cell transplantation.
- received myeloablative conditioning
- Karnofsky score ≥70.
- creatinine clearance ≥60 mL/min (according to the Cockcroft-Gault formula). (7) liver and kidney function: aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of the normal range (ULN), total bilirubin ≤ 2 × ULN; serum creatinine ≤ 1.5 × ULN.
- 8) left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography (ECHO). 9) life expectancy >12 weeks. 10) Voluntarily signed the consent form and could understand and comply with the requirements of the study.
Who cannot join
- Active autoimmune disease, such as SLE, rheumatoid arthritis, etc.
- Current clinically significant active cardiovascular disease such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by New York Heart Association (NYHA) functional class, or a history of myocardial infarction within 6 months prior to enrollment.
- Other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes).
- human immunodeficiency virus (HIV) infection.
- cirrhosis of the liver, active hepatitis.
- Pregnant or lactating women.
- Patients who are concurrently enrolled in any clinical trials of similar drugs.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, 310006
About this study
Low Dose Ruxolitinib with Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor plus Methotrexate and Mycophenolate mofetil as Graft Versus Host Disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.
Read the detailed description
The is a prospective, randomized two-arm, and multicenter study. To compare the efficacy and safety of low-dose ruxolitinib combined with calcineurin inhibitor and methotrexate vs. calcineurin inhibitor plus methotrexate and mycophenolate mofetil as graft versus host disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.
- Conditions
- Graft Versus Host Disease
- Being tested
- Ruxolitinib+Calcineurin inhibitor+Methotrexate, Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil
- Keywords
- Graft Versus Host Disease, ruxolitinib, HLA-haploidentical hematopoietic stem cell transplantation
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib+Calcineurin inhibitor+MethotrexateDrug
low-dose ruxolitinib combine with calcineurin inhibitor and short course of methotrexate.
Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetilDrug
calcineurin inhibitor and short course of methotrexate and mycophenolate mofetil
| Study group | Role | What they receive |
|---|---|---|
| RUX group | Experimental | Not described Receives: Drug: Ruxolitinib+Calcineurin inhibitor+Methotrexate |
| Control group | Active comparator | Not described Receives: Drug: Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
100-day cumulative II-IV aGVHD incidence after HSCT
Cumulative incidence of grade II-IV acute GVHD occurring within the first 100 days following transplantation.
Measured: From the date of transplantation to the first occurrence of grade II-IV acute GVHD, assessed up to 100 days.
Secondary outcomes (7)
Cumulative Incidence of Chronic GVHD
The cumulative incidence of chronic GVHD following transplantation.n
Measured: From the date of transplantation to the first diagnosis of chronic GVHD, assessed up to 3 years.
Overall Survival
Overall survival following is defined as the time from transplantation to death from any cause.
Measured: From the date of transplantation until death from any cause, assessed up to 3 years.
Adverse Events
Incidence and type adverse events following transplantation.
Measured: From the date of transplantation to day 180 post-transplantation.
Cumulative Incidence of Relapse
Cumulative incidence of disease relapse following transplantation is defined as the time from transplantation to the first documented disease recurrence.
Measured: From the date of transplantation to the first documented relapse, assessed up to 3 years.
GVHD-Free, Relapse-Free Survival
GVHD-free, relapse-free survival is defined as the time from transplantation to the first occurrence of grade III-IV acute GVHD, chronic GVHD requiring systemic therapy, disease relapse, or death from any cause.
Measured: From the date of transplantation to the first occurrence of grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD, relapse, or death, assessed up to 3 years.
Non-Relapse Mortality
Non-relapse mortality is defined as death without evidence of relapse or progression of the primary disease following transplantation.
Measured: From the date of transplantation to death without prior relapse or disease progression, assessed up to 3 years.
Relapse-Free Survival
Relapse-free survival is defined as the time from transplantation to the first documented relapse of the underlying disease or death from any cause.
Measured: From the date of transplantation to the first documented relapse or death from any cause, assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Hospital of Zhejiang University School of Medicine, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ruijin Hospital, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838704
- Sponsor's protocol ID
- RCMvsCM
- Status last verified
- May 2025
- First submitted
- 5 Apr 2021
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu H, Shi W, Shi Z, Luo Y, Yu J, Cao W, Cao J, Xu X, Hu X, Lu Y, Fu H, Liu L, Lai X, Yang L, Ye Y, Zhang C, Shi J, Huang H, Zhao Y. Low-dose ruxolitinib for graft-versus-host disease prevention in haploidentical haematopoietic stem-cell transplantation: a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Haematol. 2026 Aug;13(8):e533-e544. doi: 10.1016/S2352-3026(26)00167-5.
PubMed 42532067
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruxolitinib With Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04838704
- Acronym / sponsor ID
- RCMvsCM
- Conditions
- Graft Versus Host Disease
- Keywords
- Graft Versus Host Disease, ruxolitinib, HLA-haploidentical hematopoietic stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- The Children's Hospital of Zhejiang University School of Medicine, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Ruijin Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 9 Apr 2021 (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.
Low Dose Ruxolitinib with Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor plus Methotrexate and Mycophenolate mofetil as Graft Versus Host Disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.
Detailed description
The is a prospective, randomized two-arm, and multicenter study. To compare the efficacy and safety of low-dose ruxolitinib combined with calcineurin inhibitor and methotrexate vs. calcineurin inhibitor plus methotrexate and mycophenolate mofetil as graft versus host disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RUX group | Experimental | Drug: Ruxolitinib+Calcineurin inhibitor+Methotrexate |
| Control group | Active comparator | Drug: Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be diagnosed with malignant hematological disease.
- aged 12-70 years.
- Received HLA-haploidentical hematopoietic stem cell transplantation.
- received myeloablative conditioning
- Karnofsky score ≥70.
Key exclusion criteria (7 listed)
- Active autoimmune disease, such as SLE, rheumatoid arthritis, etc.
- Current clinically significant active cardiovascular disease such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by New York Heart Association (NYHA) functional class, or a history of myocardial infarction within 6 months prior to enrollment.
- Other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes).
- human immunodeficiency virus (HIV) infection.
- cirrhosis of the liver, active hepatitis.
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 |
|---|---|---|
| Ruxolitinib+Calcineurin inhibitor+Methotrexatelow-dose ruxolitinib combine with calcineurin inhibitor and short course of methotrexate. | Drug | RUX group |
| Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetilcalcineurin inhibitor and short course of methotrexate and mycophenolate mofetil | Drug | Control group |
Primary outcome
100-day cumulative II-IV aGVHD incidence after HSCT
Time frame: From the date of transplantation to the first occurrence of grade II-IV acute GVHD, assessed up to 100 days.
Cumulative incidence of grade II-IV acute GVHD occurring within the first 100 days following transplantation.
7 secondary outcomes
Cumulative Incidence of Chronic GVHD
Time frame: From the date of transplantation to the first diagnosis of chronic GVHD, assessed up to 3 years.
Overall Survival
Time frame: From the date of transplantation until death from any cause, assessed up to 3 years.
Adverse Events
Time frame: From the date of transplantation to day 180 post-transplantation.
Cumulative Incidence of Relapse
Time frame: From the date of transplantation to the first documented relapse, assessed up to 3 years.
GVHD-Free, Relapse-Free Survival
Time frame: From the date of transplantation to the first occurrence of grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD, relapse, or death, assessed up to 3 years.
Non-Relapse Mortality
Time frame: From the date of transplantation to death without prior relapse or disease progression, assessed up to 3 years.
Relapse-Free Survival
Time frame: From the date of transplantation to the first documented relapse or death from any cause, assessed up to 3 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Derived from this study: PubMed 42532067Wu H, Shi W, Shi Z, Luo Y, Yu J, Cao W, Cao J, Xu X, Hu X, Lu Y, Fu H, Liu L, Lai X, Yang L, Ye Y, Zhang C, Shi J, Huang H, Zhao Y. Low-dose ruxolitinib for graft-versus-host disease prevention in haploidentical haematopoietic stem-cell transplantation: a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Haematol. 2026 Aug;13(8):e533-e544. doi: 10.1016/S2352-3026(26)00167-5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ruxolitinib+Calcineurin inhibitor+Methotrexate and Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil in people with Graft Versus Host Disease, run by Zhejiang 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 7 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: finished, as of the sponsor's last update on 4 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
100-day cumulative II-IV aGVHD incidence after HSCT (time frame: From the date of transplantation to the first occurrence of grade II-IV acute GVHD, assessed up to 100 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04838704, which also lists 1 linked publication.
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 4 Jun 2025.