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The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will receive a treatment regimen consisting of the Anti-CD25 rhMAb in combination with prednisone, cyclosporine, and ruxolitinib.The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-CD25 rhMAb + traditional therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD25 rhMAb | Drug | 1 mg/kg/day administered IV day 1, 4, and 8, then weekly for 6 doses. For patients achieving partial remission, an extra dose of Anti-CD25 rhMAb can be given on days 39 and 49. |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate (ORR) | ORR is defined as the percentage of complete response (CR) and partial response (PR). | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| duration of response（DOR） | DOR is defined as the duration calculated from the time of achieving PR or CR until the progression of GVHD, the addition of other systemic immunosuppressive therapy, or death. | 1 year |
| patient-reported outcomes (PRO) |
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Inclusion Criteria:
Exclusion Criteria:
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Our plan is to disseminate the findings of this trial via peer-reviewed articles.
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| C540383 | ruxolitinib |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Prednisone | Drug | Maintain pre-screening dose |
|
| Ruxolitinib | Drug | 10mg, BID PO |
|
| Cyclosporine | Drug | 1.25mg/kg, BID PO/IV, target:150-250ng/ml |
|
the unabbreviated scale title is the Lee Chronic GVHD Symptom Scale.the minimum and maximum are 0 and 100, and higher scores mean a worse outcome.
| 1 year |
| disease-free survival (DFS) | DFS is defined as the duration of survival after treatment in which the original hematologic disease is in a state of complete remission. | 1 year |
| failure-free survival (FFS) | Events that are considered as failures include the onset of new chronic GVHD, relapse, and death. | 1 year |
| non-relapse mortality (NRM) | NRM is defined as death due to reasons other than progression/relapse of hematologic disease. | 1 year |
| overall survival （OS） | OS is defined as the time from treatment until death from any cause or the last follow-up. | 1 year |
| adverse drug reactions (ADR) | The occurrence of various organ toxicities related to treatment that emerge following treatment. | 1 year |
| Best Overall Response Rate (ORR) of Overall cGVHD | CR + PR Rate of Overall cGVHD | 1 year |
| Immune Reconstitution | Humoral immune reconstitution (IgM, IgA, and IgG)；Cellular immune reconstitution parameters (CD3⁺, CD4⁺, CD8⁺, and CD19⁺ cell subsets) | 1 year |
| Quality of Life Assessment | SF-36 Questionnaire；FACT-BMT Questionnaire | 1 year |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |