Single center phase II clinical study for acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation treated with lucotinib and glucocorticoid

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000031618

Enrollment

Unknown

Registered

2020-04-05

Start date

2020-06-08

Completion date

Unknown

Last updated

2020-06-08

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 corticosteroid

Eligibility

Sex/Gender

All

Age

12 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are fully informed and sign informed consent by themselves or their guardians; 2. Patients who can swallow tablets; 3. Patients receiving allogeneic hematopoietic stem cell transplantation; 4. Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation; 5. Patients with stable implantation of granulocytes and platelets.

Exclusion criteria

Exclusion criteria: 1. Patients who have received more than one transplant; 2. Patients with overlap syndrome; 3. Patients within six months after the failure of the first transplantation; 4. Patients with uncontrollable active infection; 5. Patients with recurrence of primary malignant hematopathy; 6. Patients with DLI or induced graft-versus-host disease after first intervention; 7. Patients with serious respiratory diseases; 8. Patients with severe renal insufficiency; 9. Patients with serious and uncontrolled heart disease; 10. Patients with severe hepatobiliary diseases unrelated to graft-versus-host disease; 11. Within one week patients who need to use more than 1mg/kg/d methylprednisolone for reasons other than graft-versus-host disease; 12. Patients taking anticoagulant or antiplatelet drugs; 13. Patients with a history of progressive multifocal leukoencephalopathy (PML); 14. Patients who need to use other JAK inhibitors for other reasons after transplantation; 15. patients who have participated in other clinical trials within 1 month; 16. 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; 17. Patients who are allergic or intolerable to ruxolitinib.

Design outcomes

Primary

Measure	Time frame
ORR at 7 days;	—

Secondary

Measure	Time frame
ORR at 28 days;Non-relapse mortality;Relapse;Overall Survival;Relapse-related mortality;Failure-free survival;Clinical safety data;chronic GVHD;	—

Countries

China

Contacts

Public ContactHuang Xiaojun

Beijing University People's Hospital

huangxiaojun@bjmu.edu.cn+86 13701389625

Outcome results

None listed

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