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Clinical Randomized Controlled Study on First-Line Treatment of Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation With Lucotinib and Low-Dose Glucocorticoid

Clinical Randomized Controlled Study on First-Line Treatment of Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation With Lucotinib and Low-Dose Glucocorticoid

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041035
Enrollment
Unknown
Registered
2020-12-16
Start date
2020-12-15
Completion date
Unknown
Last updated
2021-03-01

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

Conditions

Acute graft-versus-host disease

Interventions

Case series:Ruxolitinib and low-dose corticosteroid

Sponsors

Blood Diseases hospital, Institute of Hematology, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients receiving allogeneic hematopoietic stem cell transplantation and acute graft-versus-host disease of grade II-IV were diagnosed after transplantation by clinical or biopsy confirmation; 2. Patients who can swallow tablets; 3. Patients with age >= 15 years old and < 65 years old are not limited to men and women. 4. For patients who have to sign the informed consent form before the start of the research procedure, the informed consent form shall be signed by the patient himself or his immediate family member for patients aged 18 and above; the informed consent form shall be signed by the legal guardian for children and adolescents under the age of 18.

Exclusion criteria

Exclusion criteria: 1. Patients with DLI or induced graft-versus-host disease after first intervention; 2. Patients with uncontrollable active infection; 3. Patients with overlap syndrome or chronic GVHD; 4. Patients who are allergic or intolerable to ruxolitinib. 5. Within one week patients who need to use more than 1mg/kg/d methylprednisolone for reasons other than graft-versus-host disease; 6. Patients who need to use other JAK inhibitors for other reasons after transplantation; 7. Patients who have participated in other clinical trials within 1 month; 8. Suffering from mental disorders or other conditions and unable to meet the requirements of research, treatment and monitoring; 9. Pregnant patients or patients who can not take appropriate contraceptive measures during treatment; 10. The researcher judges that there are other factors that are not suitable for participating in the study, or participating in the study will bring great risks to the patients;

Design outcomes

Primary

MeasureTime frame
ORR of aGVHD;

Secondary

MeasureTime frame
OS;RFS;RR;TRM;T cell subsets;levels of the cytokines;Treatment-emergent adverse events;

Countries

China

Contacts

Public ContactJiang Erlie

Blood Diseases Hospital, Institute of Hematology, Chinese Academy of Medical Sciences

jiangerlie@ihcams.ac.cn+86 15122538106

Outcome results

None listed

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