Intensity-modulated total marrow irradiation for high-risk blood cancers
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
This study is testing a new type of radiation treatment combined with standard chemotherapy to see if it helps people with high-risk blood cancers feel better after receiving stem cell transplants.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Drugs / interventions | radiation, Cyclophosphamide, fludarabine, chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06802315 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with high-risk AML, CML, or MDS who meet specific clinical criteria.
Not a fit: Patients with low-risk forms of these blood cancers or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and reduce relapse in patients with high-risk blood cancers.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination of TMI and chemotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- University of Illinois Cancer Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Matias Sanchez, MD — University of Illinois at Chicago
- Study coordinator: Matias Sanchez, MD
- Email: matiass@uic.edu
- Phone: (312) 413-4260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.