MTX and Steroid as First-line Therapy for aGVHD

Acute GVH Disease Clinical Trial

Official title:

A Multi-cohort, Phase Ⅲ Study of Methotrexate Combined Corticosteroid as First-line Therapy in Chinese Patients With Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04960644
• Other study ID #: NFEC-202105-K3-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 25, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 157
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute GVH Disease

Intervention

Drug:
• MTX
MTX (5-10 mg/day,Dmax 10mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR
• Corticosteroid
corticosteroid Methylprednisolone 1 mg/kg/day was given for 10 days and then the dosage was gradually reduced according to patient's response

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	cGVHD	The cumulative incidence of chronic GVHD	1 years
Secondary	Infection and poor graft function	The cumulative incidence of severe infection and poor graft function	1 year
Secondary	Relapse	The cumulative incidence of relapse	1 year
Secondary	Non-relapse mortality	The cumulative incidence of non-relapse mortality	1 year
Secondary	Overall survival	The cumulative incidence of overall survival	1 year
Secondary	Disease free survival	The cumulative incidence of disease free survival	1 year