Immune Reconstitution to CMV After HSCT: Impact of Clinical Factors and Therapy Strategies

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Dec 12, 2022

Keywords

ClinConnect Summary

This is an observational study that looks at how the immune system recovers CMV-specific (virus-fighting) cells after an allogeneic hematopoietic stem cell transplant (HSCT). Researchers will follow adults up to about 1 year after transplant to see how CMV-related infections behave and how immune cells change over time. Participants will be grouped by common clinical approaches: one group gets Letermovir to prevent CMV, and the other group receives preemptive treatment guided by CMV testing when the virus is detected. The main questions are how often CMV infection that needs treatment occurs, how often CMV infection stays or becomes difficult to treat, and how the immune cells (like NK and T cells) change during recovery.

Eligible people are adults aged 14 to 75 who are having their first allogeneic HSCT and can consent to blood tests. People with CMV disease in the last 6 months, major organ problems, or rapidly worsening illness are not eligible. The study is led by Peking University People’s Hospital in Beijing and plans to enroll about 120 participants, with follow-up about a year. Participants can expect regular blood tests to measure immune cells and CMV activity, plus monitoring for other viral infections and overall survival. This is not a randomized trial; clinicians will use Letermovir or preemptive therapy based on clinical needs and patient preference. The study aims to better understand factors that influence CMV immunity after transplant and how different treatment strategies might help.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be receiving a first allogeneic HSCT.
• • Is male or female, from 14 years to any years of age inclusive.
• • The participant (or legally acceptable representative) agree for cellular immune investigation and has provided documented informed consent/assent for the study.
• Exclusion Criteria:
• • Received a previous allogeneic HSCT (Note: Receipt of a previous autologous HSCT is acceptable).
• • Has a history of CMV end-organ disease within 6 months prior to allocation.
• • Has severe organ (hepatic , renal, cardical) insufficiency within 5 days prior to allocation.
• • Any rapidly-progressing disease or immediately life-threatening illness.