Acute GVHDPhase 2NCT03701698
Ruxolitinib and Steroid As First Line Therapy for Acute GVHD
A Phase 2 study testing Ruxolitinib Oral Tablet and Methylprednisolone in people with Acute GVHD, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of ruxolitinib in combination with methylprednisolone as first line therapy in patients with Grades II to IV acute graft-versus-host disease (GVHD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute GVHD
- What is being tested?
- Ruxolitinib Oral Tablet and Methylprednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 20 Sep 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with hematological diseases.
- recipients of allogeneic peripheral blood stem cell transplantation.
- new onset of grade II~IV acute graft versus host disease within 100 days post-transplantation.
Who cannot join
- recipients of second allogeneic stem cell transplant.
- acute GVHD induced by donor lymphocyte infusion, interferon.
- received treatment other than steroid before enrollment.
- overlap GVHD syndrome.
- pregnant or breast-feeding women.
- absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L
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- non-GVHD related liver dysfunction: glutamic pyruvic transaminase>= 4 times of upper normal limit, direct bilirubin >= 4 times of upper normal limit
- renal dysfunction: creatinine clearance < 15 mL/min or glomerular filtration rate< 15 mL/min
- uncontrolled infection
- human immunodeficiency virus infection
- active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
- relapse of primary malignant hematological diseases, or graft rejection.
- allergic history to Janus kinase inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ruxolitinib and Methylprednisolone As First Line Therapy for Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation
The purpose of this study is to evaluate the efficacy of ruxolitinib in combination with methylprednisolone as first line therapy in patients with Grades II to IV acute graft-versus-host disease (GVHD).
Read the detailed description
Treatment:
Once patients are diagnosed with grade II~IV acute GVHD, the combination therapy should be initiated as soon as possible.
- Methylprednisolone: 2mg/kg/d, iv or iv gtt, in two or three divided doses. Taper steroid every one or two weeks according to patient's response.
- Ruxolitinib 5~10mg bid po for at least 28 days. If patient's ANC<0.5×10e9/L or PLT< 20×10e9/L, cease ruxolitinib until recovery of ANC higher than 0.5×10e9/L or PLT higher than 20×10e9/L.
Indication for stopping Ruxolitinib treatment:
- No response after ruxolitinib treatment for 28 days.
- Develop life-threatening complication.
- ANC<0.5×10e9/L or PLT< 20×10e9/L.
Indication for second line acute GVHD treatment:
- deterioration of acute GVHD in 3 days
- no response after 7 days
- no complete remission after 2 weeks.
Suggestions of second line therapy:
Basiliximab 20mg, d1, d4, d8.
- Conditions
- Acute GVHD
- Being tested
- Ruxolitinib Oral Tablet, Methylprednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib Oral TabletDrug
Also called Jakafi
Ruxolitinib Oral Tablet （Jakafi）, 5~10mg bid po for at least 28 days.
Also called steroid
Methylprednisolone: 2mg/kg/d , iv or iv gtt, for at least 1 week, then taper accordingly.
| Study group | Role | What they receive |
|---|---|---|
| combination therapy | Experimental | There is only 1 arm. Combination therapy arm includes ruxolitinib and methylprednisolone.
1. Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response.
2. Ruxolitinib oral tablet, 5~10mg bid orally, for at least 28 days. Receives: Drug: Ruxolitinib Oral Tablet; Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
overall response rate of acute GVHD treatment, including complete response rate and partial response rate after combination therapy.
Measured: 28 days after treatment
Secondary outcomes (3)
time to response
days from beginning to the first day of maximum response
Measured: 28 days after treatment
reactivation rate of cytomegalovirus
reactivation rate of cytomegalovirus infection
Measured: 100 days within transplant
1 year incidence of chronic GVHD
incidence of chronic GVHD 1 year after transplant
Measured: 1 year within transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start1 Nov 2018
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Why it stopped: Participants recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GVHDStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xianmin Song, M.D., Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701698
- Sponsor's protocol ID
- SHSYXY-Ruxo-GVHD-2018001
- Status last verified
- Sep 2024
- First submitted
- 8 Oct 2018
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruxolitinib and Methylprednisolone As First Line Therapy for Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03701698
- Acronym / sponsor ID
- SHSYXY-Ruxo-GVHD-2018001
- Conditions
- Acute GVHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participants recruitment failure
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 10 Oct 2018 (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 purpose of this study is to evaluate the efficacy of ruxolitinib in combination with methylprednisolone as first line therapy in patients with Grades II to IV acute graft-versus-host disease (GVHD).
Detailed description
Treatment:
Once patients are diagnosed with grade II~IV acute GVHD, the combination therapy should be initiated as soon as possible.
- Methylprednisolone: 2mg/kg/d, iv or iv gtt, in two or three divided doses. Taper steroid every one or two weeks according to patient's response.
- Ruxolitinib 5~10mg bid po for at least 28 days. If patient's ANC<0.5×10e9/L or PLT< 20×10e9/L, cease ruxolitinib until recovery of ANC higher than 0.5×10e9/L or PLT higher than 20×10e9/L.
Indication for stopping Ruxolitinib treatment:
- No response after ruxolitinib treatment for 28 days.
- Develop life-threatening complication.
- ANC<0.5×10e9/L or PLT< 20×10e9/L.
Indication for second line acute GVHD treatment:
- deterioration of acute GVHD in 3 days
- no response after 7 days
- no complete remission after 2 weeks.
Suggestions of second line therapy:
Basiliximab 20mg, d1, d4, d8.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combination therapy | Experimental | Drug: Ruxolitinib Oral Tablet, Drug: MethylprednisoloneThere is only 1 arm. Combination therapy arm includes ruxolitinib and methylprednisolone. 1. Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response. 2. Ruxolitinib oral tablet, 5~10mg bid orally, for at least 28 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with hematological diseases.
- recipients of allogeneic peripheral blood stem cell transplantation.
- new onset of grade II~IV acute graft versus host disease within 100 days post-transplantation.
Key exclusion criteria (13 listed)
- recipients of second allogeneic stem cell transplant.
- acute GVHD induced by donor lymphocyte infusion, interferon.
- received treatment other than steroid before enrollment.
- overlap GVHD syndrome.
- pregnant or breast-feeding 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 |
|---|---|---|
| Ruxolitinib Oral TabletAlso: JakafiRuxolitinib Oral Tablet （Jakafi）, 5~10mg bid po for at least 28 days. | Drug | combination therapy |
| MethylprednisoloneAlso: steroidMethylprednisolone: 2mg/kg/d , iv or iv gtt, for at least 1 week, then taper accordingly. | Drug | combination therapy |
Primary outcome
overall response rate
Time frame: 28 days after treatment
overall response rate of acute GVHD treatment, including complete response rate and partial response rate after combination therapy.
3 secondary outcomes
time to response
Time frame: 28 days after treatment
reactivation rate of cytomegalovirus
Time frame: 100 days within transplant
1 year incidence of chronic GVHD
Time frame: 1 year within transplant
Results and safety
The study was stopped early (reason given: Participants recruitment failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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.
Xianmin Song, M.D. principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 Ruxolitinib Oral Tablet and Methylprednisolone in people with Acute GVHD, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 13 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: stopped early, as of the sponsor's last update on 1 Oct 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?
The study was stopped early (reason given: Participants recruitment failure). Results are not available in the source record.
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?
overall response rate (time frame: 28 days after treatment). 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 1 Oct 2024.