NCT06802315RecruitingPhase 2
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 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
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 28 Jan 2025
- Start date
- 4 Feb 2025
- Primary completion date
- Mar 2030
- Lead sponsor
- University of Illinois Chicago
- NCT number
- NCT06802315
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 38
- From 4 Feb 2025 to the primary completion date, Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 4\. Patients previously received radiation to \>20% of bone marrow-containing areas.
Other illness
- 6f. Active viral hepatitis or HIV infection.
Lab values
- 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.
Other
- 1\. Presence of significant co-morbidity as shown by:
- 4d. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia.
- 5e. Karnofsky score \<70
- 7g. Cirrhosis.
- 2\. Pregnancy or breast feeding
- 3\. Patients unable to sign informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.