A Phase 2 interventional study of Intensity modulated total marrow irradiation and Cyclophosphamide (CTX) in Acute Myeloid Leukemia, Relapsed, Adult, Acute Myeloid Leukemia Refractory and Chronic Myeloid Leukemia - Accelerated Phase, sponsored by University of Illinois at Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by University of Illinois at Chicago · Phase 2, Interventional, and Treatment
The study is a Phase II clinical trial. Patients will receive intensity-modulated total marrow irradiation (TMI) at a dose of 9 Gray (Gy) with standard myeloablative fludarabine intravenous (IV) and targeted busulfan (FluBu4) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (GVHD) prophylaxis will include Cyclophosphamide on Day +3 and +4, tacrolimus, and mycophenolate mofetil.
Patients will receive the following conditioning regimen: fludarabine 40 mg/m2 IV piggyback daily, from day -5 (5 days before stem cell infusion) through Day -2, IV busulfan targeting a 4800 μM/min/ day, from day -5 through day -2. In addition to the above chemotherapy, all patients will receive TMI at a dose of 3Gy on days -3, -2, and -1. On day 0, the stem cell product will be infused according to BMT (Bone Marrow Transplant) unit policy. Graft versus host disease (GVHD) prophylaxis will consist of the administration of Cyclophosphamide 50 mg/Kg on days 3 and 4 and mycophenolate mofetil combined with tacrolimus. Post-transplant evaluation will be done per standard care with study data collected at days 30, 60, 90, 180, 365, and 2 years.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 38 is close to the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Days -5 through -2: Fludarabine 40 mg/m2 IVPB daily and Busulfan targeting AUC 4800μM/min daily Day -3 through -1: Intensity modulated total marrow irradiation (9Gy fractionated) Day 0: Infuse peripheral blood mobilized stem cells Days +3 and +4: Cyclophosphamide 50 mg/kg/day Day 5: Mycophenolate mofetil and Tacrolimus (dose adjustment dependent on trough level) Day 30: Follow up Day 60: Follow up Day 90: Follow up Day 180: Follow up 1. year: Follow up 2. year: Follow up
Radiation: Intensity modulated total marrow irradiation · Drug: Cyclophosphamide (CTX) · Drug: Fludarabine (Fludara) · Drug: Busulfan (conditioning for ALLO Transplant)
See "Treatment Regimen"
This study will determine the safety of the combination of Total Marrow Irradiation (TMI) and Post-Transplant Cyclophosphamide using a myeloablative fludarabine and iv targeted busulfan (Flu/Bu4) conditioning regimen.
chemotherapy conditioning
chemotherapy conditioning
GVHD-Free Relapse-Free Survival after Stem Cell Transplant
The 1-year GVHD- free relapse-free survival after HSCT (hematopoietic stem cell transplantation) conditioned with a 9Gy TMI in combination with FluBu4 and PTCY in patients with acute myeloid leukemia (AML), chronic myeloid leukemia (CML), Myelodysplastic Syndrome (MDS) at high risk of relapse.
Time frame: 1 Year Post-Stem Cell Transplant
Overall Survival
The number of participants who have overall survival
Time frame: 2 Years Post-Stem Cell Transplant
Time To Engraftment
Time frame: 30 Days Post-Stem Cell Transplant
Adverse Events
The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0) and the Bearman scale.
Time frame: 30 Days Post-Stem Cell Transplant
Adverse Events
The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0).
Time frame: 60 Days Post-Stem Cell Transplant
Adverse Events
The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0)
Time frame: 90 Days Post-Stem Cell Transplant
Adverse Events
The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0).
Time frame: 180 Days Post-Stem Cell Transplant
Adverse Events
The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0).
Time frame: 1 Year Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
The number of participants with Acute Graft Versus Host Disease
Time frame: 30 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
The number of participants with Acute Graft Versus Host Disease
Time frame: 60 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
The number of participants with Acute Graft Versus Host Disease
Time frame: 90 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
The number of participants with Acute Graft Versus Host Disease
Time frame: 180 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
The number of participants with Acute Graft Versus Host Disease
Time frame: 1 Year Post-Stem Cell Transplant
Incidence of Chronic Graft Versus Host Disease
The number of participants with Chronic Graft Versus Host Disease
Time frame: 180 Days Post-Stem Cell Transplant
Incidence of Chronic Graft Versus Host Disease
The number of participants with Chronic Graft Versus Host Disease
Time frame: 1 Year Post-Stem Cell Transplant
Transplant-Related Mortality
The number of participants with transplant-related mortality
Time frame: 30 Days Post-Stem Cell Transplant
Transplant-Related Mortality
The number of participants with transplant-related mortality
Time frame: 60 Days Post-Stem Cell Transplant
Transplant-Related Mortality
The number of participants with transplant-related mortality
Time frame: 90 Days Post-Stem Cell Transplant
Transplant-Related Mortality
The number of participants with transplant-related mortality
Time frame: 180 Days Post-Stem Cell Transplant
Transplant-Related Mortality
The number of participants with transplant-related mortality
Time frame: 1 Year Post-Stem Cell Transplant
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Studies of the drugs tested here: Cyclophosphamide · Fludarabine phosphate · Busulfan
University of Illinois at Chicago →