Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification

Launched by SHANGHAI GENERAL HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at ways to help patients with very high-risk myelodysplastic syndromes (MDS) who have undergone a stem cell transplant. The goal is to see if a specific treatment can prevent the return of their disease and improve their chances of surviving without relapse for one to two years after the transplant. Researchers will collect data on how well patients do after their transplant and compare it to what has been seen in the past.

To participate in this trial, you must be between 18 and 70 years old, have been diagnosed with MDS, and have a compatible stem cell donor. You should also be in good overall health, with specific criteria for your organ function. If you join the study, you can expect to receive close monitoring and support as you go through the treatment process. This trial is currently recruiting participants and aims to find better ways to help those at high risk for relapse after their transplant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 70 years, inclusive, both male and female. Diagnosed with MDS according to WHO criteria and classified as very high-risk by IPSS-M scoring. The patient must have a suitable hematopoietic stem cell donor for allogeneic transplantation: Related donors must be at least 5/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1
• • 2. Unrelated donors must be at least 8/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score of ≤ 2. ECOG performance status of 0-2. Adequate liver, kidney, cardiac, and pulmonary functions as follows: Serum creatinine ≤ 1.5× upper limit of normal (ULN)
• • 3. Cardiac function: Ejection fraction ≥ 50%
• • 4. Baseline oxygen saturation \> 92%
• • 5. Total bilirubin ≤ 1.5× ULN
• • 6. ALT and AST ≤ 2.0× ULN
• • 7. Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 ≥ 50%. Patients must be capable of understanding and willing to participate in the study, and must sign an informed consent form.
• Exclusion Criteria:
• • 1. Failure to proceed with stem cell reinfusion after unsuccessful pre-transplant conditioning. History of previous hematopoietic stem cell transplantation (HSCT). ECOG performance status \> 2. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3. Any unstable systemic disease including, but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within the past 3 months, myocardial infarction within the past 3 months, congestive heart failure (New York Heart Association \[NYHA\] class ≥ III), post-pacemaker implantation requiring medication for severe arrhythmias, severe liver, kidney, or metabolic diseases
• • 2. patients with pulmonary arterial hypertension. Active, uncontrolled infection: hemodynamic instability related to infection, new symptoms or signs of worsening infection, radiological evidence of new infectious foci, persistent fever without signs or symptoms that cannot exclude infection. Need for treatment for Grade ≥2 epilepsy, paralysis, aphasia, new cerebral infarction, severe brain trauma, dementia, Parkinson\'s disease, schizophrenia. HIV infection. Active hepatitis B (HBV) or hepatitis C (HCV) requiring antiviral treatment
• • 3. patients at risk of HBV reactivation, indicated by positive hepatitis B surface antigen or core antibody without antiviral therapy for hepatitis B. Pregnant or breastfeeding women. Men and women of childbearing potential unwilling to use contraception during the treatment and for 12 months post-treatment. Allergic to intervention drugs such as azacitidine, decitabine, or venetoclax.