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) (BMT-13)

June 23, 2026 updated by: Matias Sanchez, University of Illinois at Chicago

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Matias Sanchez, MD
  • Phone Number: (312) 413-4260
  • Email: matiass@uic.edu

Study Contact Backup

  • Name: Marisol Vega, MPH
  • Phone Number: (312) 413-5035
  • Email: vegam35@uic.edu

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).
  • 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.

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Regimen

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
See "Treatment Regimen"
Drug: 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: Fludarabine (Fludara)
chemotherapy conditioning
Drug: Busulfan (conditioning for ALLO Transplant)
chemotherapy conditioning

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 Year Post-Stem Cell Transplant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 2 Years Post-Stem Cell Transplant
The number of participants who have overall survival
2 Years Post-Stem Cell Transplant
Time To Engraftment
Time Frame: 30 Days Post-Stem Cell Transplant
30 Days Post-Stem Cell Transplant
Adverse Events
Time Frame: 30 Days Post-Stem Cell Transplant
The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0) and the Bearman scale.
30 Days Post-Stem Cell Transplant
Adverse Events
Time Frame: 60 Days Post-Stem Cell Transplant
The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0).
60 Days Post-Stem Cell Transplant
Adverse Events
Time Frame: 90 Days Post-Stem Cell Transplant
The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0)
90 Days Post-Stem Cell Transplant
Adverse Events
Time Frame: 180 Days Post-Stem Cell Transplant
The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0).
180 Days Post-Stem Cell Transplant
Adverse Events
Time Frame: 1 Year Post-Stem Cell Transplant
The number of adverse events and grades of severity per Common Terminology of Criteria for Adverse Events (version 5.0).
1 Year Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
Time Frame: 30 Days Post-Stem Cell Transplant
The number of participants with Acute Graft Versus Host Disease
30 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
Time Frame: 60 Days Post-Stem Cell Transplant
The number of participants with Acute Graft Versus Host Disease
60 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
Time Frame: 90 Days Post-Stem Cell Transplant
The number of participants with Acute Graft Versus Host Disease
90 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
Time Frame: 180 Days Post-Stem Cell Transplant
The number of participants with Acute Graft Versus Host Disease
180 Days Post-Stem Cell Transplant
Incidence of Acute Graft Versus Host Disease
Time Frame: 1 Year Post-Stem Cell Transplant
The number of participants with Acute Graft Versus Host Disease
1 Year Post-Stem Cell Transplant
Incidence of Chronic Graft Versus Host Disease
Time Frame: 180 Days Post-Stem Cell Transplant
The number of participants with Chronic Graft Versus Host Disease
180 Days Post-Stem Cell Transplant
Incidence of Chronic Graft Versus Host Disease
Time Frame: 1 Year Post-Stem Cell Transplant
The number of participants with Chronic Graft Versus Host Disease
1 Year Post-Stem Cell Transplant
Transplant-Related Mortality
Time Frame: 30 Days Post-Stem Cell Transplant
The number of participants with transplant-related mortality
30 Days Post-Stem Cell Transplant
Transplant-Related Mortality
Time Frame: 60 Days Post-Stem Cell Transplant
The number of participants with transplant-related mortality
60 Days Post-Stem Cell Transplant
Transplant-Related Mortality
Time Frame: 90 Days Post-Stem Cell Transplant
The number of participants with transplant-related mortality
90 Days Post-Stem Cell Transplant
Transplant-Related Mortality
Time Frame: 180 Days Post-Stem Cell Transplant
The number of participants with transplant-related mortality
180 Days Post-Stem Cell Transplant
Transplant-Related Mortality
Time Frame: 1 Year Post-Stem Cell Transplant
The number of participants with transplant-related mortality
1 Year Post-Stem Cell Transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matias Sanchez, MD, University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-0865

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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