acute graft-versus-host disease
Conditions
Interventions
Cohort A:Ruxolitinib + CSA + MTX + MMF, from +1 day
Cohort B:Ruxolitinib+CSA+MTX+MMF, from neutrophil engraftment confirmation day
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with acute leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, chronic myeloid leukemia, and lymphoma diagnosed according to the 2017 WHO Classification of Hematopoietic and Lymphoid Tissue Tumors’’; patients with aplastic anemia diagnosed according to the ‘’Chinese Expert Consensus on the Diagnosis and Treatment of Aplastic Anemia (2017 Edition)’’. the indications for transplantation refer to the Chinese Expert Consensus on Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Diseases (2014 Edition). 2. Those who received allogeneic hematopoietic stem cell transplantation (including HLA-matched or incompatible allogeneic hematopoietic stem cell transplantation and transplantation from unrelated donors). 3. Aged >= 15 years and < 65 years, no gender limit. 4. Eastern Cooperative Oncology Group Performance Status Assessment (ECOG-PS) 0-2 points. 5. The informed consent form must be signed before the start of the research procedure. Those aged 18 years and above must sign the informed consent form by themselves or their immediate family members; adolescent patients under the age of 18 must sign the informed consent form by their legal guardian.
Exclusion criteria
Exclusion criteria: 1. Received hematopoietic stem cell transplantation within the past 1 year; 2. GVHD has occurred before enrollment; 3. There is an uncontrolled active infection, including a significant bacterial, fungal, viral or parasitic infection requiring treatment; 4. Evidence of active viral infection (confirmed by peripheral blood viral load assay), including CMV, EBV, HBV or HCV, HIV; 5. Evidence of active tuberculosis; 6. Severe respiratory disease; 7. Suffering from mental disorders and unable to cooperate with the requirements of research treatment and monitoring; 8. Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment; 9. Those who are known to be allergic to any component of ruxolitinib; 10. There is severe renal impairment, defined as serum creatinine > 2 mg/dL; 11. Clinically significant or uncontrolled heart disease; 12. Cholestatic disease, or unrelieved hepatic sinusoidal obstruction syndrome/hepatic veno-occlusive disease; 13. Those who are deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of aGVHD;neutral and platelet implantation time; | — |
Secondary
| Measure | Time frame |
|---|---|
| the incidence of virus reaction;overall survival;recurrence rate;transplant related mortality;Ruxolitinib side effect; | — |
Countries
China
Contacts
Public ContactWang Fuxu
The Second Hospital of Hebei Medical University
Outcome results
None listed