Transplant-Related Disorder
Conditions
Brief summary
This study aims to evaluate the efficacy of prophylactic ruxolitinib in adult patients at intermediate-to-high risk of severe acute GvHD, as predicted by the daGOAT model.
Interventions
DRUGRuxolitinib
1. Model-predicted high-risk patients: will receive standard prophylaxis plus ruxolitinib 5mg twice daily (bid) orally until at least day 60 post-transplantion and will be terminated after day 100. If severe hematological signs occur such as when there is severe neutropenia (\<0.1×10\^9/L), ruxolitinib can be used at half dose or discontinued until recovery. 2. Model-predicted moderate-risk patients: will receive standard prophylaxis plus ruxolitinib 5mg once daily (qd) orally until at least day 60 post-transplantion and will be terminated after day 100. If severe hematological signs occur such as when there is severe neutropenia (\<0.1×10\^9/L), ruxolitinib can be used at half dose or discontinued until recovery. 3. Model-predicted low-risk patients: will receive standard prophylaxis without additional GvHD prophylactic agents, including mesenchymal cell infusion, anti-CD25 monoclonal antibodies, and ruxolitinib outside the scope specified in the study protocol.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 16 years old. 2. HLA-haploidentical transplant. 3. Able to take oral medications. 4. Patients must provide written informed consent before the start of the study procedures.
Exclusion criteria
1. Patients who have undergone tandem transplantation or multiple transplantations. 2. Patients who are allergic to or cannot tolerate ruxolitinib. 3. Patients with mental or other medical conditions that make them unable to comply with the study treatment and monitoring requirements. 4. Patients who are ineligible for the study due to other factors, or who will bear great risk if they participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe aGVHD during 100 days after transplantation according to the MAGIC criteria | 100 days after transplantation | Incidence of severe aGVHD after transplantation within 100 days. The medical records for each case wil be reviewed by two or three physicians to confirm the aGVHD diagnosis and grading (according to the MAGIC criteria) |
Secondary
| Measure | Time frame |
|---|---|
| Severe aGVHD during 180 days after transplantation according to the MAGIC criteria | 180 days after transplantation |
| aGVHD in various target organs according to the MAGIC criteria | 180 days after transplantation |
| Overall survival | 1.5 year after transplantation |
| Relapse-free survival rate | 1.5 year after transplantation |
| Relapse rate | 1.5 year after transplantation |
Contacts
CONTACTYahui Feng
Outcome results
None listed