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).
Study 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.
Eligibility
Sex
ALL
Min age
15 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Overall response rate (ORR) for aGVHD treatment after treatment — 14 days 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
Trial sites (2)
Facility
City
Region
Status
Peking University Institute of Hematology,
Beijing
Beijing Municipality
Recruiting
Nanfang Hospital, Nanfang Medical University
Guangzhou
Guangdong
Recruiting
More Peking University People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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