Study on Intensity Modulated Total Marrow Irradiation (IM-TMI) for Bone Marrow Transplant Patients

Sponsor: University of Illinois at Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04187105

Provider View

This clinical trial is testing a new approach to prepare patients for a bone marrow transplant using targeted radiation therapy, along with medications to prevent complications after the transplant.

Patient Parameters

Program Overview

The study aims to evaluate a new method of preparing patients for a bone marrow transplant by using targeted total marrow irradiation (TMI) at a specific dose. This is combined with medications to prevent graft-versus-host disease, a common complication after transplant. The trial will involve patients receiving a standard treatment regimen before the transplant, which includes specific chemotherapy drugs and radiation therapy.

Description

This clinical trial is focused on testing a new way to prepare patients for a bone marrow transplant. The process involves using targeted total marrow irradiation (TMI) at a dose of 6Gy, along with a standard treatment regimen that includes chemotherapy drugs like fludarabine and cyclophosphamide, and total body irradiation (TBI). After the transplant, patients will receive medications such as cyclophosphamide, tacrolimus, and mycophenolate mofetil to help prevent graft-versus-host disease, a condition where the transplanted cells attack the patient's body. The study is designed to see if this approach is safe and effective for patients undergoing a haploidentical hematopoietic stem cell transplant (HSCT).

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 75 years.
  • Have a related donor who is at least a partial match in specific genetic markers, or an unrelated donor with certain mismatches.
  • Diagnosed with specific types of blood cancers or conditions, such as:
    • Relapsed or hard-to-treat acute leukemia.
    • Poor-risk acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) in first remission.
    • Myelodysplastic syndromes (MDS) with certain high-risk features.
  • Have adequate heart, liver, and lung function as determined by specific medical tests.

Exclusion Criteria

  • Have significant health issues, such as:
    • Poor heart function.
    • High levels of bilirubin or liver enzymes, unless due to specific conditions.
    • Poor lung function.
    • Low performance status score.
    • History of liver cirrhosis.
  • Unable to provide informed consent.
  • Have previously received radiation to a large portion of bone marrow areas.

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