Low Dose Methotrexate Combined with Low Dose Methylprednisolone for the Treatment of Acute Graft-Versus-Host Disease: Randomized, Controlled, Prospective Clinical Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000466

Enrollment

Unknown

Registered

2009-07-24

Start date

2007-05-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute GVHD after bone marrow transplant

Interventions

A:Methotrexate (10mg/time), intravenously on d1, d3, d8, d15, and once every 7 days afterwards

combined with methylprednisolone: day 1 through 5, 0.5mg/kg/d

day 6 through 12, 0.25mg/kg/d

day 13 through 19, 0.125mg/kg/d and dose was reduced by half after 5-7 days

B:Methylprednisolone (1-2mg/kg/d) , and dose will be reduced by half after 5-7 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with aGVHD after hematopoietic stem cells transplantation (including bone marrow stem cells, mobilized peripheral blood stem cells or umbilical cord blood stem cells); 2. Peripheral white blood cell count >1.5*10^9/l.

Exclusion criteria

Exclusion criteria: 1. Allergic constitution ot allegic to certain drugs; 2. Patients had received other medication of immunodepressant; 3. Participated in any other clinical trial in the past 1 months.

Design outcomes

Primary

Measure	Time frame
Grading of acute graft versus host disease;	—

Countries

China

Contacts

Public ContactXiaojun Huang

xjhrm@medmail.com.cn+86 010 88326006

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026