Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic Syndrome

Launched by WUHAN UNION HOSPITAL, CHINA · Jan 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment plans for adults with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who are preparing for a type of stem cell transplant called allogeneic hematopoietic stem cell transplantation (HSCT). The researchers want to find out which of the two “reduced intensity conditioning” regimens—fludarabine plus busulfan or fludarabine plus melphalan—is safer and more effective for patients who are either older than 55 years or have a specific health complication score.

To be eligible for this trial, participants must be at least 18 years old, diagnosed with AML or MDS, and have a compatible donor for their stem cell transplant. They should also have a health score of 3 or higher, or be aged 55 and older. If someone joins the study, they will be randomly assigned to receive one of the two treatment plans. Participants will be closely monitored throughout the trial to gather important information about their health and the effectiveness of the treatments. This research aims to improve outcomes for patients facing these serious conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age equal or more than 18 years old.
• • Patients diagnosed with AML or MDS.
• • Patients who have related or unrelated bone marrow or peripheral blood donors and plan to undergo hematopoietic stem cell transplantation.
• • Hct-specific complication index score (HCT-CI) more than or equal to 3 or the age of Patients ≥55 years.
• • Sign the informed consent, promise to abide by the research procedures, and cooperate with the implementation of the whole process of the research.
• Exclusion Criteria:
• • Patients with central nervous system involvement.
• • Patients with HIV seropositive.
• • Patients with other serious diseases and a life expectancy of less than six months
• • Patients with severe mental or psychological disorders.
• • Patients without written informed consent.