Study on Targeted Radiation and Chemotherapy Before Stem Cell Transplant for High-Risk Leukemia and Myelodysplastic Syndrome

Sponsor: University of Illinois at Chicago

Sponsor score: 0

ClinicalTrials ID:NCT06802315

Provider View

This clinical trial is testing a new approach using targeted radiation and chemotherapy before a stem cell transplant to treat patients with high-risk types of leukemia and myelodysplastic syndrome. The study aims to improve treatment outcomes by using a combination of therapies to prepare the body for the transplant.

Patient Parameters

Program Overview

This Phase II study is exploring a treatment plan that includes targeted radiation called intensity-modulated total marrow irradiation (TMI) and chemotherapy before a stem cell transplant. The goal is to see if this approach can help patients with high-risk acute myeloid leukemia (AML), chronic myeloid leukemia (CML), and myelodysplastic syndrome (MDS) by better preparing their bodies for the transplant. The treatment includes radiation, chemotherapy, and medications to prevent complications after the transplant.

Description

In this study, patients will receive a combination of treatments to prepare for a stem cell transplant. This includes:

  • Chemotherapy with fludarabine and busulfan, given through an IV, starting five days before the transplant.
  • Targeted radiation therapy called intensity-modulated total marrow irradiation (TMI) on the three days leading up to the transplant.
  • On the day of the transplant, patients will receive the stem cells.
  • After the transplant, patients will receive medications to prevent a condition called graft-versus-host disease (GVHD), which includes cyclophosphamide, tacrolimus, and mycophenolate mofetil.

Patients will be monitored closely after the transplant, with follow-up evaluations at 30, 60, 90, 180, and 365 days, and then again at two years to assess their health and the success of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 65 years.
  • Diagnosed with high-risk acute myeloid leukemia (AML), chronic myeloid leukemia (CML), or myelodysplastic syndrome (MDS).
  • Specific conditions include:
    • AML that has returned or not responded to treatment.
    • AML in first remission with certain high-risk features.
    • MDS with poor-risk features or treatment-related MDS.
    • CML with a history of advanced stages.
  • Must meet specific medical criteria related to the type and stage of their disease.

Exclusion Criteria

  • Significant health issues such as:
    • Heart function below 50%.
    • Poor kidney function.
    • High liver enzyme levels unless due to specific conditions.
    • Poor lung function.
    • Low overall health score.
  • Active viral infections like hepatitis or HIV.
  • Liver cirrhosis.
  • Pregnant or breastfeeding women.
  • Inability to provide informed consent.
  • Previous radiation treatment to a large portion of the bone marrow.

Locations

FACILITYZIPCITYSTATE
University of Illinois Cancer Center60612ChicagoIllinois

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