The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT (NCT05596968) | Clinical Trial Compass
UnknownNot Applicable
The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT
China37 participantsStarted 2022-10-01
Plain-language summary
This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3-ITD positive AML patients after allo-HSCT in terms of gut microbiome.
Who can participate
Age range
18 Years – 65 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:
* FLT3-ITD Positive AML
* Allo-HSCT Recipients
Exclusion Criteria:
* intolerance to sorafenib pretransplantation
* Cardiac dysfunction (particularly congestive heart failure)
* Hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal)
* Renal dysfunction (creatinine clearance rate \< 30 mL/min)
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (according to the investigators' decision)
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.
1This trial is looking at how gut bacteria change during sorafenib maintenance therapy after a stem cell transplant for FLT3-ITD positive AML — given that it's listed as 'observational' in nature and focused on the gut microbiome, does this mean it's mainly collecting data about my gut bacteria rather than testing a new treatment, and how would that affect my actual care?
2Since sorafenib is already used as maintenance therapy after an allogeneic stem cell transplant for FLT3-ITD positive AML, would I be receiving sorafenib regardless of whether I join this trial, or does enrolling in this study change what treatment I'd actually get?
3The trial's recruitment status is listed as 'unknown' — do you know whether this study is still actively enrolling patients, and if not, are there similar studies investigating the gut microbiome and its relationship to outcomes after transplant that might be available to me?
4Given that this study is measuring changes in gut microbiota diversity during my recovery from a stem cell transplant, what would participating actually require from me in terms of sample collection, clinic visits, or dietary restrictions on top of what I'd already be doing?
5Are there any findings so far — from this study or related research — suggesting that gut microbiome changes during sorafenib maintenance therapy might influence my risk of graft-versus-host disease or relapse, and should that factor into any decisions we're making about my post-transplant plan?
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
Variation of Gut Microbiota Composition and Diversity
Timeframe: 3 months
Trial details
NCT IDNCT05596968
SponsorNanfang Hospital, Southern Medical University