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Intensity Modulated Total Marrow Irradiation for High-Risk Leukemias and MDS

This study is testing a new way to prepare patients for a stem cell transplant. It combines a special type of radiation called intensity modulated total marrow irradiation (TMI) with chemotherapy drugs, fludarabine and busulfan, followed by cyclophosphamide after the transplant. This approach aims to reduce the risk of the disease coming back and to prevent graft-versus-host disease (GVHD), a common complication of transplants. The study is for adults aged 18-65 with high-risk acute myeloid leukemia (AML), chronic myeloid leukemia (CML), or myelodysplastic syndrome (MDS). Researchers will measure how many patients are free from GVHD and relapse one year after their transplant. The current recruitment status is unclear.

Study design
This is a Phase II interventional study planning to enroll 38 participants. It is a single-arm study, meaning all participants receive the same treatment.
What's involved
You would receive chemotherapy (fludarabine and busulfan) and TMI radiation for several days before your stem cell transplant. After the transplant, you would receive cyclophosphamide, tacrolimus, and mycophenolate mofetil. You would have follow-up evaluations at specific times for two years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years after their stem cell transplant, with evaluations at specific intervals.

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NCT06802315

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)

Recruiting
PHASE2Ages 18–65InterventionalTreatment
University of Illinois at Chicago
~38 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Intensity modulated total marrow irradiationCyclophosphamide (CTX)Fludarabine (Fludara)Busulfan (conditioning for ALLO Transplant)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
GVHD-Free Relapse-Free Survival after Stem Cell Transplant
Measured over 1 Year Post-Stem Cell Transplant

Conditions

Acute Myeloid Leukemia, Relapsed, Adult
Acute Myeloid Leukemia Refractory
Chronic Myeloid Leukemia - Accelerated Phase
Myelodysplastic Syndromes

Explore related trials

Acute Myeloid LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Matias Sanchez, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

Who to contact

Matias Sanchez, MD
[email protected]
(312) 413-4260
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • GVHD-Free Relapse-Free Survival after Stem Cell Transplant1 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.