Steroids Combined With Ruxolitinib as First-Line Therapy for Grade II Acute Graft-versus-Host Dis… (NCT07576010) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Steroids Combined With Ruxolitinib as First-Line Therapy for Grade II Acute Graft-versus-Host Disease
China30 participantsStarted 2025-01-17
Plain-language summary
This study aims to evaluate the efficacy and safety of low-dose corticosteroids combined with ruxolitinib in the treatment of grade II acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation.
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation, including MDS-RAEB, acute leukemia, and chronic phase of CML.
* Availability of an HLA-matched sibling donor, unrelated donor, or haploidentical donor.
* Age ≥ 14 years.
* Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 2 × ULN.
* Renal function: serum creatinine ≤ ULN.
* Absence of uncontrolled infection or severe psychiatric/psychological disorders.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Signed informed consent.
* Diagnosis of grade II acute GVHD as assessed by the modified Glucksberg grading criteria for acute GVHD.
Exclusion Criteria:
* Absence of an allogeneic donor.
* Pregnancy of either the donor or the recipient.
* Presence of psychiatric disorders or other conditions that preclude compliance with the study protocol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.