TBF Conditioning Regimen for Haploidentical Stem Cell Transplantation in Elderly AML Patients in … (NCT07563920) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
TBF Conditioning Regimen for Haploidentical Stem Cell Transplantation in Elderly AML Patients in First Complete Remission
93 participantsStarted 2026-06
Plain-language summary
Acute myeloid leukemia (AML) is a serious blood cancer that mainly affects older adults. For patients who achieve their first complete remission (CR1), allogeneic hematopoietic stem cell transplantation (HSCT) may provide a chance for long-term survival. However, relapse after transplantation remains a major challenge.
This study aims to evaluate the effectiveness and safety of a conditioning regimen that combines thiotepa, busulfan, and fludarabine (TBF) before haploidentical peripheral blood stem cell transplantation (haplo-PBSCT) in elderly patients with AML in first complete remission.
Eligible patients will receive the TBF conditioning regimen followed by stem cell transplantation from a partially matched donor. Participants will be followed to assess relapse-free survival, overall survival, transplant-related complications, and infections.
The results of this study may help improve treatment strategies and outcomes for elderly AML patients undergoing transplantation.
Who can participate
Age range
55 Years – 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:
* Age 55 to 75 years
* Diagnosed with acute myeloid leukemia (AML) based on morphology, immunophenotyping, cytogenetics, or molecular testing
* First complete remission (CR1) or complete remission with incomplete hematologic recovery (CRi)
* Eligible for haploidentical hematopoietic stem cell transplantation
* Availability of a suitable haploidentical donor
* ECOG performance status 0-2
* Adequate organ function:
* Left ventricular ejection fraction ≥50%
* Oxygen saturation \>92% on room air
* Serum creatinine ≤1.5 × upper limit of normal (ULN)
* Total bilirubin ≤1.5 × ULN
* AST and ALT ≤2.0 × ULN
* DLCO ≥40% and FEV1 ≥50%
* Ability to understand and sign informed consent
Exclusion Criteria:
* Secondary AML (including AML evolving from myelodysplastic syndrome or therapy-related AML)
* Active, uncontrolled infection
* Severe uncontrolled systemic disease (e.g., unstable cardiovascular disease, recent stroke, or severe organ dysfunction)
* HIV infection
* Active hepatitis B or C requiring antiviral treatment
* Pregnant or breastfeeding women
* Known hypersensitivity to study drugs
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
1-year Relapse-Free Survival (RFS)
Timeframe: 12 months after transplantation
Trial details
NCT IDNCT07563920
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine