Study on Total Marrow and Lymphoid Irradiation with Fludarabine and Melphalan for Older Patients Undergoing Stem Cell Transplant for Difficult Leukemia and Myelodysplastic Syndrome

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT07582172

Provider View

This clinical trial is exploring a new treatment approach for older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that hasn't responded to previous treatments or has returned. The study combines targeted radiation therapy with chemotherapy before a stem cell transplant from a donor.

Patient Parameters

Program Overview

This study is testing a new treatment method for older patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that hasn't responded to previous treatments or has come back. The treatment involves using targeted radiation therapy called Total Marrow and Lymphoid Irradiation (TMLI) along with chemotherapy drugs fludarabine and melphalan before a stem cell transplant from a donor. This approach aims to reduce side effects and improve the effectiveness of the transplant by preparing the body to accept new, healthy blood-forming cells. The study will evaluate if this combination is safe and effective for older patients.

Description

The main goal of this study is to see if using Total Marrow and Lymphoid Irradiation (TMLI) with chemotherapy drugs fludarabine and melphalan before a stem cell transplant can help older patients with difficult-to-treat acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) live longer without the disease returning. The study will also look at the safety of this treatment combination, including any side effects and how well patients recover after the transplant.

Participants will receive a series of treatments, including radiation therapy and chemotherapy, to prepare their bodies for the transplant. The transplant involves receiving healthy stem cells from a donor, which can help the patient's bone marrow produce healthy blood cells and potentially eliminate remaining cancer cells.

The study will monitor participants for side effects, survival rates, and any signs of the disease returning. Researchers will also collect blood and bone marrow samples to study the immune system's response and other factors that might affect the treatment's success. Participants will be followed up regularly for up to two years after the transplant to assess their health and quality of life.

Eligibility Criteria

Inclusion Criteria

  • Must be 50 years or older, or between 18 and 50 if not eligible for more intense treatments due to other health issues.
  • Have a confirmed diagnosis of acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
  • Have a matched donor willing to provide stem cells.
  • Be in good general health with a performance status of 70 or higher.
  • Have adequate liver, kidney, and heart function as shown by specific medical tests.
  • Not have any active infections or other serious health conditions.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for six months after.
  • Agree to provide blood and tissue samples for research purposes.

Exclusion Criteria

  • Have had a stem cell transplant within the past year.
  • Have received certain cancer treatments within 14 days before starting the study.
  • Have had more than three previous intensive chemotherapy treatments.
  • Be enrolled in other clinical trials that could affect the study's results.
  • Have a history of severe allergic reactions to similar treatments.
  • Have uncontrolled illnesses or active infections.
  • Be pregnant or breastfeeding.
  • Have any condition that the study doctor believes would make participation unsafe or difficult.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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