Efficacy and Safety of the CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning… (NCT07644481) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of the CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Adult Patients With Acute Myeloid Leukemia in First Complete Remission
30 participantsStarted 2026-07-20
Plain-language summary
This is a single-center, prospective, exploratory clinical study. It plans to enroll 30 adult patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR1) after induction therapy and meet the indications for allogeneic hematopoietic stem cell transplantation (allo-HSCT). The aim is to evaluate the efficacy and safety of allo-HSCT following conditioning regimens with clofarabine, busulfan and melphalan.
Who can participate
Age range
18 Years – 60 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
. AML classified as intermediate or adverse genetic risk according to the 2022 ELN genetic risk stratification;
. AML with positive measurable residual disease (MRD) before transplantation;
. Total bilirubin (TBIL) ≤ 2 times the upper limit of normal (ULN); Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤ 3 × ULN;
. Serum creatinine (Cr) ≤ 1.5 × ULN, or estimated creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault glomerular filtration formula;
. Coagulation function meeting the following standards: Prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (without anticoagulant therapy);
. Electrocardiogram showing no acute myocardial infarction or severe arrhythmia; Echocardiography with left ventricular ejection fraction (LVEF) ≥ 50%, without significant cardiomegaly, valvular heart disease or congenital heart disease;
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 uses a three-drug conditioning regimen called CloB2M — combining clofarabine, busulfan, and melphalan — before the stem cell transplant. How does this compare to the standard conditioning regimen you would normally recommend for my situation, and what are the main risks of using all three of these drugs together?
2The trial is listed as 'not yet recruiting,' which means no patients have enrolled yet. Does that affect how soon I might need to make a decision about transplant, and is there a standard-of-care transplant option I should be pursuing in the meantime?
3The trial is listed as Phase NA, which makes it harder to know what stage of safety or benefit testing this is at. Can you help me understand what is already known about the CloB2M regimen and what remains uncertain before I consider this as an option?
4The trial is specifically for AML patients in first complete remission. Given where I am in my treatment right now, do you think I would even be a candidate to discuss this trial with the research team once it opens?
5The main thing this trial is measuring is 2-year overall survival. Based on what you know about my specific AML risk profile, how does the survival benefit you might expect from this conditioning regimen compare to what I might get from an allogeneic transplant using a more established approach?
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
2-year Overall Survival（OS）rate
Timeframe: 2 years.
Trial details
NCT IDNCT07644481
SponsorInstitute of Hematology & Blood Diseases Hospital, China