Intensity-modulated total marrow irradiation for high-risk blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial investigates the use of intensity-modulated total marrow irradiation (TMI) combined with a standard chemotherapy regimen in patients undergoing allogeneic hematopoietic stem cell transplantation for high-risk acute myeloid leukemia (AML), chronic myeloid leukemia (CML), and myelodysplastic syndromes (MDS). Participants will receive a specific conditioning regimen of fludarabine and busulfan, followed by TMI before the stem cell infusion. The study aims to evaluate the safety and efficacy of this approach, with post-transplant evaluations conducted at various intervals to monitor patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Illinois Cancer Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Matias Sanchez, MD — University of Illinois Chicago
• Study coordinator: Matias Sanchez, MD
• Email: matiass@uic.edu
• Phone: (312) 413-4260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.