Safety and EfficacyPhase 4NCT05021276
Basiliximab Combined With Ruxolitinib as Second-line Treatment of Grade 3-4 Steroid-resistant aGVHD
A Phase 4 study testing Ruxolitinib in people with Safety and Efficacy, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The recognized first-line treatment for grade 3-4 aGVHD is systemic glucocorticoid. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Safety and Efficacy
- What is being tested?
- Ruxolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2020to 15 Dec 2022
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of primary grade 3-4(according to MAGIC criteria) steroid-resistant acute graft-versus-host disease(progression after 3 days or lack of improvement after 5 days of systemic 1.5-2 mg/kg steroids).
- Age 18-65.
- ECOG score≤3.
- Must be able to understand and willing to participate in the study and sign the informed consent.
Who cannot join
- Refractory/secondary graft-versus-host disease.
- Severe complications such as myocardial infarction, chronic cardiac insufficiency, hepatic failure, renal insufficiency, etc.
- Clinically uncontrolled active infections.
- Other Malignant tumors with progression.
- Ecg: QT interval > 450 ms.
- Allergic to arsenic agent.
Show all 9Show fewer
- Pregnant or lactating women.
- Expected survival <60 days.
- Undergoing other drug clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xuefeng He, doctor, 86-18914031640, hexuefeng@suda.edu.cn
About this study
Official title: A Prospective Multicenter, Single-arm Clinical Study of Anti-CD25 Monoclonal Antibody Combined With Ruxolitinib in the Treatment of Grade 3-4 Steroid-resistant Acute Graft-versus-host Disease
Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The recognized first-line treatment for grade 3-4 aGVHD is systemic glucocorticoid. However, there is no recognized second-line treatment for grade 3-4 steroid-resistant aGVHD (SR-aGVHD). The investigators try to observe the efficacy and safety of early application of anti-CD25 monoclonal antibody(basiliximab) combined with ruxotilinib in the treatment of severe SR-aGVHD.
Read the detailed description
Adults ages 18-65 with grade 3-4 SR-aGVHD
Design
Participants with grade 3-4 steroid-refractory acute GVHD (progression after 3 days or lack of improvement after 5 days of 1.5-2 mg/kg/d systemic steroids) receive combined therapy of basiliximab and ruxolitinib.
Basiliximab is given 20mg twice a week for week 1, and then once a week until GVHD of the participants reaches grade 1(3 episodes for minimum).
Ruxolitinib is given 5mg twice a day for one day and then escalates to 10mg twice a day if the participant is not administered with triazole antifungal agent.
The drug dose will be adjusted according to participants' clinical manifestations, blood cell count, infection status and so on.
For participants with lower gastrointestinal GVHD, intravenous cyclosporine or tacrolimus is given and plasma concentration is monitored in a safe and effective range.
Best supportive treatment is given, including broad-spectrum anti-infection, nutrition support, and blood transfusion.
The investigators access the efficacy and safety of second-line therapy once a week from day 14 until complete remission is received. Then the investigators access the hematological disease status, aGVHD, cGVHD, infection state once a month.
- Conditions
- Safety and Efficacy
- Being tested
- Ruxolitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called basiliximab
Ruxolitinib and basiliximab are both second-line treatment for grade 3-4 steroid-resistant acute graft-versus-host disease.
| Study group | Role | What they receive |
|---|---|---|
| ruxolitinib+basiliximab | Experimental | Patients with grade 3-4 steroid-refractory aGVHD receive combined therapy of basiliximab and ruxolitinib. Receives: Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate at day 28
The primary endpoint is the overall response rate (ORR) at day 28 defined as proportion of patients demonstrating partial (PR) or complete response (CR) without requirement for additional systemic immunosuppressive therapy (IST) at day 28 after second-line treatment initiates.
Measured: day 28
Secondary outcomes (7)
ORR at d14/d56
overall response rate at day 14/56
Measured: day 14, day 56
Time to response
Time to response, defined as time from the day treatment initiates to the date of first documentation PR or CR.
Measured: through study completion(median 12 days according to previous study)
Duration of response
Duration of response, assessed for responders only by calculating the time from first response to the date of first observation of aGvHD relapse/progression or the date of additional IST for GvHD.
Measured: through study completion, an average of 1year
OS
Overall survival (OS) defined as time from the day treatment initiates to the date of death from any cause.
Measured: through study completion, an average of 1year
EFS
Event-free survival (EFS) defined as the time from the day treatment initiates to the date of recurrence of underlying hematologic disease, graft failure or death due to any cause.
Measured: through study completion, an average of 1year
incidence rate of secondary grade 3-4 liver aGVHD
incidence rate of secondary grade 3-4 liver aGVHD
Measured: through study completion, an average of 1 year
incidence rated of chronic GVHD
incidence rated of chronic GVHD
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start15 Dec 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
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 Safety and EfficacyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Soochow Hopes Hematonosis Hospital, The Second People's Hospital of Huai'an
- Responsible party
- Principal investigator, Xuefeng He, The First Affiliated Hospital of Soochow University
- Investigators
- Xuefeng He, doctor, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021276
- Sponsor's protocol ID
- GVHD-001
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou F, Pan T, Li X, Du F, Ma X, Zhang Y, Wu D, Han Y, Xue S, Miao M, Tao T, He X, Chen S. Exploration of efficacy and safety of combined therapy of basiliximab with ruxolitinib for grade 3-4 steroid-refractory acute graft-versus-host disease: a registered clinical trial (NCT05021276). Bone Marrow Transplant. 2023 Aug;58(8):959-961. doi: 10.1038/s41409-023-02005-4. Epub 2023 May 30. No abstract available.
PubMed 37253803
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter, Single-arm Clinical Study of Anti-CD25 Monoclonal Antibody Combined With Ruxolitinib in the Treatment of Grade 3-4 Steroid-resistant Acute Graft-versus-host Disease
- ClinicalTrials.gov ID
- NCT05021276
- Acronym / sponsor ID
- GVHD-001
- Conditions
- Safety and Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Soochow Hopes Hematonosis Hospital, The Second People's Hospital of Huai'an
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 25 Aug 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.
Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The recognized first-line treatment for grade 3-4 aGVHD is systemic glucocorticoid. However, there is no recognized second-line treatment for grade 3-4 steroid-resistant aGVHD (SR-aGVHD). The investigators try to observe the efficacy and safety of early application of anti-CD25 monoclonal antibody(basiliximab) combined with ruxotilinib in the treatment of severe SR-aGVHD.
Detailed description
Adults ages 18-65 with grade 3-4 SR-aGVHD
Design
Participants with grade 3-4 steroid-refractory acute GVHD (progression after 3 days or lack of improvement after 5 days of 1.5-2 mg/kg/d systemic steroids) receive combined therapy of basiliximab and ruxolitinib.
Basiliximab is given 20mg twice a week for week 1, and then once a week until GVHD of the participants reaches grade 1(3 episodes for minimum).
Ruxolitinib is given 5mg twice a day for one day and then escalates to 10mg twice a day if the participant is not administered with triazole antifungal agent.
The drug dose will be adjusted according to participants' clinical manifestations, blood cell count, infection status and so on.
For participants with lower gastrointestinal GVHD, intravenous cyclosporine or tacrolimus is given and plasma concentration is monitored in a safe and effective range.
Best supportive treatment is given, including broad-spectrum anti-infection, nutrition support, and blood transfusion.
The investigators access the efficacy and safety of second-line therapy once a week from day 14 until complete remission is received. Then the investigators access the hematological disease status, aGVHD, cGVHD, infection state once a month.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ruxolitinib+basiliximab | Experimental | Drug: RuxolitinibPatients with grade 3-4 steroid-refractory aGVHD receive combined therapy of basiliximab and ruxolitinib. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of primary grade 3-4(according to MAGIC criteria) steroid-resistant acute graft-versus-host disease(progression after 3 days or lack of improvement after 5 days of systemic 1.5-2 mg/kg steroids).
- Age 18-65.
- ECOG score≤3.
- Must be able to understand and willing to participate in the study and sign the informed consent.
Key exclusion criteria (9 listed)
- Refractory/secondary graft-versus-host disease.
- Severe complications such as myocardial infarction, chronic cardiac insufficiency, hepatic failure, renal insufficiency, etc.
- Clinically uncontrolled active infections.
- Other Malignant tumors with progression.
- Ecg: QT interval > 450 ms.
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 |
|---|---|---|
| RuxolitinibAlso: basiliximabRuxolitinib and basiliximab are both second-line treatment for grade 3-4 steroid-resistant acute graft-versus-host disease. | Drug | ruxolitinib+basiliximab |
Primary outcome
overall response rate at day 28
Time frame: day 28
The primary endpoint is the overall response rate (ORR) at day 28 defined as proportion of patients demonstrating partial (PR) or complete response (CR) without requirement for additional systemic immunosuppressive therapy (IST) at day 28 after second-line treatment initiates.
7 secondary outcomes
ORR at d14/d56
Time frame: day 14, day 56
Time to response
Time frame: through study completion(median 12 days according to previous study)
Duration of response
Time frame: through study completion, an average of 1year
OS
Time frame: through study completion, an average of 1year
EFS
Time frame: through study completion, an average of 1year
incidence rate of secondary grade 3-4 liver aGVHD
Time frame: through study completion, an average of 1 year
incidence rated of chronic GVHD
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 37253803Zhou F, Pan T, Li X, Du F, Ma X, Zhang Y, Wu D, Han Y, Xue S, Miao M, Tao T, He X, Chen S. Exploration of efficacy and safety of combined therapy of basiliximab with ruxolitinib for grade 3-4 steroid-refractory acute graft-versus-host disease: a registered clinical trial (NCT05021276). Bone Marrow Transplant. 2023 Aug;58(8):959-961. doi: 10.1038/s41409-023-02005-4. Epub 2023 May 30. No abstract available.
- 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.
Xuefeng He, doctor principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ruxolitinib in people with Safety and Efficacy, run by The First Affiliated Hospital of Soochow 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 4 inclusion and 9 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 25 Aug 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xuefeng He, doctor (86-18914031640, hexuefeng@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate at day 28 (time frame: day 28). 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 NCT05021276, 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 25 Aug 2021.