Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD

Acute Graft Versus Host Disease Clinical Trial

Official title:

Randomized Trial of Mini-dose Methotrexate Plus Standard-dose Steroid vs Steroids for the Initial Treatment of Acute Graft Versus Host Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921305
• Other study ID #: GVHD-MTX-Randomized trial
• Status: Recruiting
• Phase: Phase 3
• Start date: August 3, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Peking University People's Hospital
• Contact: Yu Wang, M.D.
• Phone: 86-13552647384
• Email: ywyw3172[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.

Description:

Allo-HSCT is an effective treatment of malignant hematopoietic diseases. However, aGVHD remains a major complication after allo-HSCT. Corticosteroid is the standard first-line therapy for aGVHD. 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 control aGVHD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• 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 first allogeneic hematopoietic stem cell transplantation;

3. Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;

4. KPS>60, Estimated survival >3 months;

5. No serious organ damage:

1. ANC in peripheral blood is greater than 0.5×109/l

2. Creatinine < 1.5mg/dl

3. Cardiac ejection index > 55%

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

8. Patients who received donor lymphocyte infusion

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• MTX
MTX (5mg/m^2/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR
• Corticosteroid
Corticosteroid Methylprednisolone 2 mg/kg/day was given for 3 days, and for responding patients, the dose of prednisone must be at least 0.25mg/kg/day prednisone (or 0.2mg/kg/day methylprednisolone).

Locations

Country	Name	City	State
China	Peking University Institute of Hematology,	Beijing	Beijing
China	Nanfang Hospital, Nanfang Medical University	Guangzhou	Guangdong

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	14 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