Acute Myeloid Leukemia, Relapsed, AdultPhase 2BMT-13NCT06802315
Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)
A Phase 2 study testing Intensity modulated total marrow irradiation, Cyclophosphamide (CTX) and Fludarabine (Fludara) in people with Acute Myeloid Leukemia, Relapsed, Adult and Acute Myeloid Leukemia Refractory, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Relapsed, Adult, Acute Myeloid Leukemia Refractory, Chronic Myeloid Leukemia - Accelerated Phase
- What is being tested?
- Intensity modulated total marrow irradiation, Cyclophosphamide (CTX) and Fludarabine (Fludara)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to Mar 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 18-65 years.
- 2. Patients with CML, AML, or MDS who meet one of the following criteria: 2a. Relapsed or refractory AML (including AML in CR2) 2b. Poor-risk AML in first remission, with remission defined as <5% bone marrow blasts morphologically:
- AML arising from MDS, a myeloproliferative disorder, or secondary AML
- Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
- Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (> 3 abnormalities), inv (3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7. 2c. Primary refractory disease 2d. MDS with at least one of the following poor-risk features:
- Poor-risk cytogenetics including 3q abnormalities, 7/7q minus or complex cytogenetics (>3 abnormalities).
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- Current or previous INT-2 or high IPSS score.
- Treatment-related MDS.
- MDS diagnosed before the age of 21 years.
- Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy.
- Life-threatening cytopenias, including those requiring regular PRBC or platelet transfusions. 2e. CML with a history of accelerated or blast phase.
Who cannot join
- 1. Presence of significant co-morbidity as shown by:
- 1a. Left ventricular ejection fraction < 50%
- 2b. Creatinine clearance <30ml/min.
- 3c. Bilirubin > 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST > 5 x ULN.
- 4d. FEV1 and FVC < 50% of predicted or DLCO <50% of predicted once corrected for anemia.
- 5e. Karnofsky score <70
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- 6f. Active viral hepatitis or HIV infection.
- 7g. Cirrhosis.
- 2. Pregnancy or breast feeding
- 3. Patients unable to sign informed consent.
- 4. Patients previously received radiation to >20% of bone marrow-containing areas.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612
Matias Sanchez, MD, (312) 413-4260, matiass@uic.edu
Marisol Vega, MPH, (312) 413-5035, vegam35@uic.edu
About this study
Official title: A Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Myeloablative Fludarabine/Busulfan and Post-Transplant Cyclophosphamide (PTCY) for Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk AML, CML, and MDS
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.
Read the detailed description
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.
- Conditions
- Acute Myeloid Leukemia, Relapsed, Adult, Acute Myeloid Leukemia Refractory, Chronic Myeloid Leukemia - Accelerated Phase, Myelodysplastic Syndromes
- Being tested
- Intensity modulated total marrow irradiation, Cyclophosphamide (CTX), Fludarabine (Fludara), Busulfan (conditioning for ALLO Transplant)
- Keywords
- Total Marrow Irradiation, Stem Cell Transplant, Allogenic Transplant
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence, Leukemia, Myeloid, Accelerated Phase, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity modulated total marrow irradiationRadiation
See "Treatment Regimen"
Cyclophosphamide (CTX)Drug
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.
Fludarabine (Fludara)Drug
chemotherapy conditioning
Busulfan (conditioning for ALLO Transplant)Drug
chemotherapy conditioning
| Study group | Role | What they receive |
|---|---|---|
| Treatment Regimen | Experimental | 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 Receives: Radiation: Intensity modulated total marrow irradiation; Drug: Cyclophosphamide (CTX); Drug: Fludarabine (Fludara); Drug: Busulfan (conditioning for ALLO Transplant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year Post-Stem Cell Transplant
Secondary outcomes (19)
Overall Survival
The number of participants who have overall survival
Measured: 2 Years Post-Stem Cell Transplant
Time To Engraftment
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 1 Year Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
The number of participants with Acute Graft Versus Host Disease
Measured: 30 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
The number of participants with Acute Graft Versus Host Disease
Measured: 60 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
The number of participants with Acute Graft Versus Host Disease
Measured: 90 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
The number of participants with Acute Graft Versus Host Disease
Measured: 180 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
The number of participants with Acute Graft Versus Host Disease
Measured: 1 Year Post-Stem Cell Transplant
Incidence of Chronic Graft Versus Host Disease
The number of participants with Chronic Graft Versus Host Disease
Measured: 180 Days Post-Stem Cell Transplant
Incidence of Chronic Graft Versus Host Disease
The number of participants with Chronic Graft Versus Host Disease
Measured: 1 Year Post-Stem Cell Transplant
Transplant-Related Mortality
The number of participants with transplant-related mortality
Measured: 30 Days Post-Stem Cell Transplant
Transplant-Related Mortality
The number of participants with transplant-related mortality
Measured: 60 Days Post-Stem Cell Transplant
Transplant-Related Mortality
The number of participants with transplant-related mortality
Measured: 90 Days Post-Stem Cell Transplant
Transplant-Related Mortality
The number of participants with transplant-related mortality
Measured: 180 Days Post-Stem Cell Transplant
Transplant-Related Mortality
The number of participants with transplant-related mortality
Measured: 1 Year Post-Stem Cell Transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start4 Feb 2025
- Primary completionMar 2030 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, Relapsed, AdultStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matias Sanchez, University of Illinois Chicago
- Investigators
- Matias Sanchez, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802315
- Sponsor's protocol ID
- 2024-0865
- Acronym
- BMT-13
- Status last verified
- Jun 2026
- First submitted
- 28 Jan 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Myeloablative Fludarabine/Busulfan and Post-Transplant Cyclophosphamide (PTCY) for Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk AML, CML, and MDS
- ClinicalTrials.gov ID
- NCT06802315
- Acronym / sponsor ID
- BMT-13 / 2024-0865
- Conditions
- Acute Myeloid Leukemia, Relapsed, Adult, Acute Myeloid Leukemia Refractory, Chronic Myeloid Leukemia - Accelerated Phase, Myelodysplastic Syndromes
- Keywords
- Total Marrow Irradiation, Stem Cell Transplant, Allogenic Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Regimen | Experimental | Radiation: Intensity modulated total marrow irradiation, Drug: Cyclophosphamide (CTX), Drug: Fludarabine (Fludara), Drug: Busulfan (conditioning for ALLO Transplant)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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Age 18-65 years.
- 2. Patients with CML, AML, or MDS who meet one of the following criteria: 2a. Relapsed or refractory AML (including AML in CR2) 2b. Poor-risk AML in first remission, with remission defined as <5% bone marrow blasts morphologically:
- AML arising from MDS, a myeloproliferative disorder, or secondary AML
- Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
- Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (> 3 abnormalities), inv (3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7. 2c. Primary refractory disease 2d. MDS with at least one of the following poor-risk features:
Key exclusion criteria (11 listed)
- 1. Presence of significant co-morbidity as shown by:
- 1a. Left ventricular ejection fraction < 50%
- 2b. Creatinine clearance <30ml/min.
- 3c. Bilirubin > 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST > 5 x ULN.
- 4d. FEV1 and FVC < 50% of predicted or DLCO <50% of predicted once corrected for anemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity modulated total marrow irradiationSee "Treatment Regimen" | Radiation | Treatment Regimen |
| Cyclophosphamide (CTX)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. | Drug | Treatment Regimen |
| Fludarabine (Fludara)chemotherapy conditioning | Drug | Treatment Regimen |
| Busulfan (conditioning for ALLO Transplant)chemotherapy conditioning | Drug | Treatment Regimen |
Primary outcome
GVHD-Free Relapse-Free Survival after Stem Cell Transplant
Time frame: 1 Year Post-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.
19 secondary outcomes
Overall Survival
Time frame: 2 Years Post-Stem Cell Transplant
Time To Engraftment
Time frame: 30 Days Post-Stem Cell Transplant
Adverse Events
Time frame: 30 Days Post-Stem Cell Transplant
Adverse Events
Time frame: 60 Days Post-Stem Cell Transplant
Adverse Events
Time frame: 90 Days Post-Stem Cell Transplant
Adverse Events
Time frame: 180 Days Post-Stem Cell Transplant
Adverse Events
Time frame: 1 Year Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
Time frame: 30 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
Time frame: 60 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
Time frame: 90 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
Time frame: 180 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
Time frame: 1 Year Post-Stem Cell Transplant
Incidence of Chronic Graft Versus Host Disease
Time frame: 180 Days Post-Stem Cell Transplant
Incidence of Chronic Graft Versus Host Disease
Time frame: 1 Year Post-Stem Cell Transplant
Transplant-Related Mortality
Time frame: 30 Days Post-Stem Cell Transplant
Transplant-Related Mortality
Time frame: 60 Days Post-Stem Cell Transplant
Transplant-Related Mortality
Time frame: 90 Days Post-Stem Cell Transplant
Transplant-Related Mortality
Time frame: 180 Days Post-Stem Cell Transplant
Transplant-Related Mortality
Time frame: 1 Year Post-Stem Cell Transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matias Sanchez, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensity modulated total marrow irradiation, Cyclophosphamide (CTX) and Fludarabine (Fludara) in people with Acute Myeloid Leukemia, Relapsed, Adult and Acute Myeloid Leukemia Refractory, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matias Sanchez, MD ((312) 413-4260, matiass@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GVHD-Free Relapse-Free Survival after Stem Cell Transplant (time frame: 1 Year Post-Stem Cell Transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.