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

Phase 3RecruitingNCT05921305

Peking University People's Hospital218 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

218

Conditions

Acute Graft Versus Host Disease

Interventions

MTXDRUG

MTX (5mg/m\^2/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR

CorticosteroidDRUG

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).

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 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

Locations (2)

Peking University Institute of Hematology,

Beijing, Beijing Municipality, China

RECRUITING

Nanfang Hospital, Nanfang Medical University

Guangzhou, Guangdong, China

RECRUITING

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: 14 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

Central Contacts

Yu Wang, M.D.

CONTACT

86-13552647384 ywyw3172@sina.com

Xiao-Jun Huang, M.D.

CONTACT

Data from ClinicalTrials.gov

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