The aim of the study is to identify the efficacy and safety of methotrexate (MTX) combined corticosteroid treatment for acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Methylprednisolone 1 mg/kg/day MTX (10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II;
Peking University Institute of Hematology,Beijing
Beijing, Beijing Municipality, China
RECRUITINGOverall response rate (ORR) for GVHD treatment at 7 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.
Time frame: 7 days
Overall response rate (ORR) 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.
Time frame: 28 days
Relapse
Relapse
Time frame: 1 year
Non-relapse mortality
Non-relapse mortality
Time frame: 1 year
Overall survival
Overall survival
Time frame: 1 year
Disease free survival
Disease free survival
Time frame: 1 year
Failure free survival
Failure free survival
Time frame: 1 year
Chronic GVHD
Chronic GVHD
Time frame: 1 year
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