Study on Total Marrow and Lymphoid Irradiation Before Stem Cell Transplant for Patients with Myelodysplastic Syndrome or Acute Leukemia

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04262843

Provider View

This clinical trial is exploring a new radiation method called total marrow and lymphoid irradiation to prepare patients with myelodysplastic syndrome or acute leukemia for stem cell transplants. The study aims to see if this method can reduce side effects while effectively preparing the body for the transplant.

Patient Parameters

Program Overview

This study is testing a new way to use radiation therapy, called total marrow and lymphoid irradiation, to prepare patients with myelodysplastic syndrome or acute leukemia for a stem cell transplant. The goal is to see if this method can deliver more targeted radiation to the bone marrow, reducing the risk of relapse while minimizing damage to healthy organs compared to traditional total body irradiation. This approach uses advanced technology to focus the radiation more precisely, potentially allowing for higher doses to the bone marrow with fewer side effects.

Description

The main goal of this study is to evaluate how well total marrow and lymphoid irradiation (TMLI) works as a preparation step before a stem cell transplant in patients with myelodysplastic syndrome or acute leukemia. The study will also look at the safety of this approach and how it affects the chances of the cancer returning and the occurrence of graft-versus-host disease (GvHD), a condition where the donor's immune cells attack the recipient's body.

Participants will receive a series of treatments before the transplant, including a specific type of radiation therapy and medications to prevent GvHD. After the transplant, patients will be closely monitored for any side effects and to see how well the treatment is working.

The study will also explore how the treatment affects the immune system and the bone marrow environment, as well as the overall health and recovery of the patients. Participants will have regular follow-up visits to track their progress and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Have a performance status score of 70 or higher, indicating good overall health.
  • Diagnosed with specific types of leukemia or myelodysplastic syndrome, meeting certain criteria for risk and treatment history.
  • Have normal liver and kidney function as indicated by specific blood tests.
  • Have a heart function of 50% or higher.
  • Have adequate lung function or oxygen levels.
  • Test negative for HIV, hepatitis B, and hepatitis C.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.
  • Must have a related donor who is a partial genetic match and no fully matched donor available.
  • Must not have received intensive cancer treatment in the three weeks before starting the study, with some exceptions for low-dose treatments.
  • Donor must be in good health, under 60 years old, and meet specific medical criteria.

Exclusion Criteria

  • Have uncontrolled infections or other serious illnesses.
  • Currently receiving other investigational treatments or intensive cancer therapies.
  • Have a history of severe allergic reactions to similar treatments.
  • Have active infections requiring antibiotics.
  • Have a history of HIV or hepatitis infections.
  • Women who are pregnant or breastfeeding.
  • Have had a previous stem cell transplant.
  • Have received extensive prior radiation therapy.
  • Have a fully matched donor available.
  • Have received more than three prior treatment regimens aimed at inducing remission.
  • Donor has active infections or medical conditions that prevent safe donation.

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