RecruitingPhase 2NCT06802315

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


Sponsor

University of Illinois at Chicago

Enrollment

38 participants

Start Date

Feb 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a newer form of full-body radiation (called intensity-modulated total marrow irradiation, or IMTMI) combined with chemotherapy as a preparation for bone marrow transplant in patients with high-risk leukemia (AML, CML) or myelodysplastic syndrome (MDS) — with the goal of reducing side effects compared to older radiation methods. **You may be eligible if...** - You are between 18 and 65 years old - You have high-risk AML, CML, or MDS — including cases that relapsed, are in remission 2 (CR2), or have poor-risk genetic features - You have a matched or partially-matched bone marrow donor - You are in adequate health to undergo transplant **You may NOT be eligible if...** - Your cancer is in active relapse with no response to treatment - You have significant heart, lung, or liver disease - You have received prior bone marrow transplant - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONIntensity modulated total marrow irradiation

See "Treatment Regimen"

DRUGCyclophosphamide (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.

DRUGFludarabine (Fludara)

chemotherapy conditioning

DRUGBusulfan (conditioning for ALLO Transplant)

chemotherapy conditioning


Locations(1)

University of Illinois Cancer Center

Chicago, Illinois, United States

View Full Details on ClinicalTrials.gov

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NCT06802315


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