MTX and Steroid as First-line Therapy for aGVHD

Peking University People's Hospital157 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

157

Conditions

Acute GVH Disease

Interventions

MTXDRUG

MTX (5-10 mg/day,Dmax 10mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR

CorticosteroidDRUG

corticosteroid Methylprednisolone 1 mg/kg/day was given for 10 days and then the dosage was gradually reduced according to patient's response

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who are fully informed and sign informed consent by themselves or their guardians; 2. Patients receiving allogeneic hematopoietic stem cell transplantation; 3. Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation; 4. Patients with stable implantation of granulocytes and platelets. 5. ECOG score ≤3 Exclusion Criteria: 1. Patients with severe brain, heart, kidney or liver dysfunction unrelated to graft-versus host disease; 2. Patients with uncontrollable active infection; 3. Patients with recurrence of primary malignant hematopathy; 4. Expected survival is less than 3 months 5. Patients who have histories of severe allergic reactions 6. Pregnant or lactating women 7. The researcher judges that there are other factors that are not suitable for participating

Locations (1)

Peking University People's Hospital

Beijing, China

Outcomes

Primary Outcomes

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

Time frame: 10 days

Secondary Outcomes

Overall response rate (ORR) for aGVHD treatment at 28 days after treatment

Time frame: 28 days

Overall response rate (ORR) for aGVHD treatment at 42 days after treatment

Time frame: 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.

Time frame: 42 days

cGVHD

The cumulative incidence of chronic GVHD

Time frame: 1 years

Infection and poor graft function

The cumulative incidence of severe infection and poor graft function

Time frame: 1 year

Data from ClinicalTrials.gov

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