Chronic GVHDEarly Phase 1NCT04146207
SHR0302 and Steroid As First Line Therapy for Chronic GVHD
A Early Phase 1 study testing SHR0302 and Prednisone in people with Chronic GVHD, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy of SHR0302 in combination with Prednisone as first line therapy in patients with moderate to severe chronic graft-versus-host disease (GVHD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic GVHD
- What is being tested?
- SHR0302 and Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesChina
- Study dates
- 2 Apr 2020to 31 Oct 2024
- Phase
- Early Phase 1
- 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
- ≥ 18 years old and ≤ 70 years old, male or female;
- Patients receiving allogeneic peripheral blood stem cell transplantation for hematological diseases;
- The primary hematological malignancies are completely relieved and are expected to be stable for at least 3 months;
- Chronic GVHD that was first attacked after transplantation and at least 100 days after transplantation, reached a moderate or severe level by NIH classification;
- There was no previous systemic treatment (including in vitro illumination [ECP]);
- The patient may be receiving other immunosuppressive agents to prevent or treat acute GVHD, but if the subject receives prednisone to prevent or treat acute GVHD, it must be <0.5 mg/kg/d or equivalent dose of other glucocorticoids;
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- The chronic GVHD that has started hormone therapy does not exceed 72 hours;
- Karnofsky score > 60 points;
- Patients must be able to understand and are willing to participate in the study and sign an informed consent form.
Who cannot join
- Can not tolerate prednisone dose 1mg / kg / d or equivalent dose of other glucocorticoids for the treatment of cGVHD;
- Receive any systemic treatment of cGVHD, except for corticosteroids that treat cGVHD within 72 hours prior to the signing of informed consent;
- Patients with GVHD overlap syndrome (NIH criteria);
- Treatment of acute GVHD has received other Jak inhibitors such as ruxolitinib;
- Pregnant or lactating women;
- The patient is judged by the investigator to have complications that may cause other risks;
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- The patient is receiving other study medications;
- Patient blood routine: ANC <1.0 × 109 / L or PLT < 50 × 109 / L;
- Non-GVHD-related liver damage: the aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio is more than 3 times normal or the direct bilirubin normal value is more than 3 times;
- Renal dysfunction: endogenous creatinine clearance (Ccr) < 50mL/min or normal serum creatinine 1.5 times or more, regardless of hemodialysis treatment;
- Uncontrolled infections: hemodynamic instability associated with infection, or new signs or signs of infection, or new infections in imaging, persistent fever without symptoms or signs and cannot be ruled out Infected person
- People living with HIV;
- Active hepatitis B (HBV), active hepatitis C (HCV) requires antiviral therapy; patients with HBV activation risk refer to patients with hepatitis B surface antigen-positive or core antibody-positive patients who are not treated with anti-HBV;
- The patient's primary malignant disease recurs and the graft is rejected;
- Those who are allergic to known JAK inhibitors.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Xianmin Song
Shanghai, Shanghai Municipality, 200080
About this study
Official title: SHR0302 and Prednisone As First Line Therapy for Chronic Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation
The purpose of this study is to evaluate the efficacy of SHR0302 in combination with Prednisone as first line therapy in patients with moderate to severe chronic graft-versus-host disease (GVHD).
Read the detailed description
Treatment: Once patients are diagnosed with chronic GVHD, the combination therapy should be initiated as soon as possible. 1. Prednisone: 1mg/kg/d po. Taper steroid every two weeks according to patient's response. 2. SHR0302 QD po. for at least 28 days. Indication for stopping SHR0302 treatment: 1. No response after SHR0302 treatment for 12 weeks. 2. Develop life-threatening complication. 3. ANC<0.5×10e9/L or PLT< 30×10e9/L.
- Conditions
- Chronic GVHD
- Being tested
- SHR0302, Prednisone
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302Drug
SHR0302 po QD
PrednisoneDrug
Prednisone 1mg/kg/d po
| Study group | Role | What they receive |
|---|---|---|
| combination therapy | Experimental | Experimental: combination therapy There is only 1 arm. Combination therapy arm includes SHR0302 and Prednisone
Prednisone 1mg/kg/d po，At the same time give SHR0302 QDpo； Receives: Drug: SHR0302; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SHR0302 and prednisone
The severity of adverse events is determined according to the CTCAE V5.0 criteria.
Measured: After the first dose of SHR0302 or prednisone until 30 days after the last dose of SHR0302 or prednisone.
Secondary outcomes (2)
Overall response rate (ORR) at week 4
Response rate at week 4 (the proportion of responders [CR or PR]) as defined by the NIH Consensus Development Project (2014)
Measured: Within 4 weeks
Overall response rate (ORR) at week 24
Response rate at week 24 (the proportion of responders [CR or PR]) as defined by the NIH Consensus Development Project (2014)
Measured: Within 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start2 Apr 2020
- Primary completion30 Sep 2024
- Study completion31 Oct 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 Chronic 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT04146207
- Sponsor's protocol ID
- SHSYXY-cGVHD-2019002
- Status last verified
- Jan 2024
- First submitted
- 25 Oct 2019
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He Q, Sun X, Niu J, Yang J, Wang Y, Huang C, Zhou K, Tong Y, Cai Y, Dong B, Wan L, Song X, Qiu H. A Novel JAK1 Inhibitor SHR0302 Combined With Prednisone for First-Line Treatment of Chronic Graft-Versus-Host Disease: A Phase I Clinical Trial. Cell Transplant. 2024 Jan-Dec;33:9636897241254678. doi: 10.1177/09636897241254678.
PubMed 38798038
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHR0302 and Prednisone As First Line Therapy for Chronic Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04146207
- Acronym / sponsor ID
- SHSYXY-cGVHD-2019002
- Conditions
- Chronic GVHD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 31 Oct 2019 (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 SHR0302 in combination with Prednisone as first line therapy in patients with moderate to severe chronic graft-versus-host disease (GVHD).
Detailed description
Treatment: Once patients are diagnosed with chronic GVHD, the combination therapy should be initiated as soon as possible. 1. Prednisone: 1mg/kg/d po. Taper steroid every two weeks according to patient's response. 2. SHR0302 QD po. for at least 28 days. Indication for stopping SHR0302 treatment: 1. No response after SHR0302 treatment for 12 weeks. 2. Develop life-threatening complication. 3. ANC<0.5×10e9/L or PLT< 30×10e9/L.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combination therapy | Experimental | Drug: SHR0302, Drug: PrednisoneExperimental: combination therapy There is only 1 arm. Combination therapy arm includes SHR0302 and Prednisone Prednisone 1mg/kg/d po，At the same time give SHR0302 QDpo； |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 18 years old and ≤ 70 years old, male or female;
- Patients receiving allogeneic peripheral blood stem cell transplantation for hematological diseases;
- The primary hematological malignancies are completely relieved and are expected to be stable for at least 3 months;
- Chronic GVHD that was first attacked after transplantation and at least 100 days after transplantation, reached a moderate or severe level by NIH classification;
- There was no previous systemic treatment (including in vitro illumination [ECP]);
Key exclusion criteria (15 listed)
- Can not tolerate prednisone dose 1mg / kg / d or equivalent dose of other glucocorticoids for the treatment of cGVHD;
- Receive any systemic treatment of cGVHD, except for corticosteroids that treat cGVHD within 72 hours prior to the signing of informed consent;
- Patients with GVHD overlap syndrome (NIH criteria);
- Treatment of acute GVHD has received other Jak inhibitors such as ruxolitinib;
- 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 |
|---|---|---|
| SHR0302SHR0302 po QD | Drug | combination therapy |
| PrednisonePrednisone 1mg/kg/d po | Drug | combination therapy |
Primary outcome
Safety and tolerability of SHR0302 and prednisone
Time frame: After the first dose of SHR0302 or prednisone until 30 days after the last dose of SHR0302 or prednisone.
The severity of adverse events is determined according to the CTCAE V5.0 criteria.
2 secondary outcomes
Overall response rate (ORR) at week 4
Time frame: Within 4 weeks
Overall response rate (ORR) at week 24
Time frame: Within 24 weeks
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 13 Nov 2024.
- Derived from this study: PubMed 38798038He Q, Sun X, Niu J, Yang J, Wang Y, Huang C, Zhou K, Tong Y, Cai Y, Dong B, Wan L, Song X, Qiu H. A Novel JAK1 Inhibitor SHR0302 Combined With Prednisone for First-Line Treatment of Chronic Graft-Versus-Host Disease: A Phase I Clinical Trial. Cell Transplant. 2024 Jan-Dec;33:9636897241254678. doi: 10.1177/09636897241254678.
- 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.
Xianmin Song, M.D. principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SHR0302 and Prednisone in people with Chronic GVHD, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites 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 9 inclusion and 15 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 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 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?
Safety and tolerability of SHR0302 and prednisone (time frame: After the first dose of SHR0302 or prednisone until 30 days after the last dose of SHR0302 or prednisone.). 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 NCT04146207, 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 13 Nov 2024.