MTX and Steroid for III-IV aGVHD Treatment

Acute Graft Versus Host Disease Clinical Trial

Official title:

A Single-cohort, Phase II Study of Methotrexate Combined Corticosteroid in Chinese Patients With Grade III-IV Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04958538
• Other study ID #: GVHD-MTX
• Status: Recruiting
• Phase: Phase 2
• Start date: April 21, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: April 2022
• Source: Peking University People's Hospital
• Contact: Yu Wang, Dr.
• Phone: 86-13552647384
• Email: ywyw3172[@]sina.com
• 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 treatment for grade III-IV acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

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: Recruiting
• Enrollment: 30
• Est. completion date: January 30, 2023
• Est. primary completion date: December 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 III-IV were diagnosed after transplantation;

4. Patients with stable implantation of granulocytes and platelets.

Exclusion Criteria:

1. Patients who have received more than one transplant;

2. Patients with overlap syndrome;

3. Patients within six months after the failure of the first transplantation;

4. Patients with uncontrollable active infection;

5. Patients with recurrence of primary malignant hematopathy;

6. Patients with donor lymphocyte infusion induced graft-versus-host disease after first intervention;

7. Patients with serious respiratory diseases;

8. Patients with severe renal insufficiency;

9. Patients with serious and uncontrolled heart disease;

10. Patients with severe hepatobiliary diseases unrelated to graft-versus host disease;

11. Within one week patients who need to use more than 1mg/kg/d methylprednisolone for reasons other than graft-versus-host disease;

12. patients who have participated in other clinical trials within 1 month;

13. The researcher judges that there are other factors that are not suitable for participating

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• Methotrexate
Methylprednisolone 2 mg/kg/day MTX (5-10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II

Locations

Country	Name	City	State
China	Peking University Institute of Hematology,	Beijing	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
Other	Safety data (side effect)	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.	1 year
Primary	Overall response rate (ORR) for GVHD 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) 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	relapse rate	Relapse rate is defined as the proportion of patients demonstrating a morphological relapse of the original malignant hematological disease	1 year
Secondary	Non-relapse mortality	Non-relapse mortality	1 year
Secondary	Overall survival	Overall survival	1 year
Secondary	Disease free survival	Disease free survival	1 year
Secondary	Failure free survival	Failure free survival	1 year
Secondary	Chronic GVHD	number of participants with chronic GVHD at one year	1 year