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The aim of the study is to identify the efficacy and safety of methotrexate (MTX) combined corticosteroid as first-line therapy for acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (alloHSCT).
Allo-HSCT is an effective treatment of malignant hematopoietic diseases. However, aGVHD remains a major complication after allo-HSCT and the destruction of recipient tissues by alloantigen-activated T cells is a key event in the development of aGVHD. Corticosteroid is the standard first-line therapy for aGVHD due to their roles in suppressing T cell responses. However, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory GVHD were poor. Thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for aGVHD. The study hypothesis: MTX combined corticosteroid treatment could help to further ameliorate the activity of T cells and control aGVHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTX and corticosteroid | Experimental | perimental: MTX and corticosteroid Methylprednisolone 1 mg/kg/day was given for 10 days and then gradually reduce the dose according to patient's response MTX (5-6mg/m^2/day,Maximum dose 10mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR |
|
| corticosteroid | Active Comparator | perimental: corticosteroid Methylprednisolone 1 mg/kg/day was given for 10 days and then gradually reduce the dose according to patient's response |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTX | Drug | MTX (5-10 mg/day,Dmax 10mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) for aGVHD treatment after treatment | Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) for aGVHD treatment at 28 days after treatment | Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao-Jun Huang, Dr. | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38664766 | Derived | Wang Y, Liu QF, Wu DP, Xu ZL, Han TT, Sun YQ, Huang F, Fan ZP, Xu N, Chen F, Zhao Y, Kong Y, Mo XD, Xu LP, Zhang XH, Liu KY, Huang XJ. Mini-dose methotrexate combined with methylprednisolone for the initial treatment of acute GVHD: a multicentre, randomized trial. BMC Med. 2024 Apr 25;22(1):176. doi: 10.1186/s12916-024-03395-y. |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Corticosteroid | Drug | corticosteroid Methylprednisolone 1 mg/kg/day was given for 10 days and then the dosage was gradually reduced according to patient's response |
|
| Overall response rate (ORR) for aGVHD treatment at 42 days after treatment |
Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response |
| 42 days |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Data collection including questionnaires at individual and group visits and physician interviews at individual visits will be used to assess participants for treatment-related adverse events. | 42 days |
| cGVHD | The cumulative incidence of chronic GVHD | 1 years |
| Infection and poor graft function | The cumulative incidence of severe infection and poor graft function | 1 year |
| Relapse | The cumulative incidence of relapse | 1 year |
| Non-relapse mortality | The cumulative incidence of non-relapse mortality | 1 year |
| Overall survival | The cumulative incidence of overall survival | 1 year |
| Disease free survival | The cumulative incidence of disease free survival | 1 year |