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| Name | Class |
|---|---|
| Soochow Hopes Hematonosis Hospital | UNKNOWN |
| The Second People's Hospital of Huai'an | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ruxolitinib+basiliximab | Experimental | Patients with grade 3-4 steroid-refractory aGVHD receive combined therapy of basiliximab and ruxolitinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib and basiliximab are both second-line treatment for grade 3-4 steroid-resistant acute graft-versus-host disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR at d14/d56 | overall response rate at day 14/56 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuefeng He, doctor | Contact | 86-18914031640 | hexuefeng@suda.edu.cn | |
| Fei Zhou, doctor | Contact | 86-15051425673 | zhoufei@suda.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xuefeng He, doctor | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37253803 | Derived | 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. |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| D000077552 | Basiliximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| 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. | 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. | 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. | 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 | through study completion, an average of 1 year |
| incidence rated of chronic GVHD | incidence rated of chronic GVHD | through study completion, an average of 1 year |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |