Decitabine for Poor Graft Function Post Allo-HSCT (NCT05907499) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Decitabine for Poor Graft Function Post Allo-HSCT
76 participantsStarted 2023-07-01
Plain-language summary
This randomized trial aims at validating the efficacy and safety of low-dose decitabine for PGF post allo-HSCT.
Who can participate
Age range
16 Years – 70 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
. Diagnosed as PGF at day 28 post-HSCT or later. PGF was defined as two or three cytopenias, absolute neutrophil count ≤ 1.5 × 109/L, platelet count ≤ 30 × 109/L, hemoglobin ≤ 85g/L, lasting for more than 2 consecutive weeks;
. Full donor chimerism;
. Primary disease in remission;
. No severe GVHD and relapse;
. ECOG: 0-2;
. Expected survival longer than 1 month
Exclusion criteria
. Allergic to decitabine;
. Active infections;
. Uncontrolled GVHD;
. Severe organ dysfunction;
. Relapse of underlying malignancies;
. Graft failure;
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.
What they're measuring
1
The treatment response
Timeframe: day +28
2
Survival
Timeframe: 1 year
Trial details
NCT IDNCT05907499
SponsorThe First Affiliated Hospital of Soochow University