Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients With Hematological Malignancies and Subjected to Treatment With Immune-checkpoint Inhibitors

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the side effects related to hormone-producing glands (endocrinological adverse events) in patients with blood cancers, like leukemia or lymphoma, who are receiving a new type of treatment called immune-checkpoint inhibitors. These treatments help the body’s immune system fight cancer. The researchers want to understand how these treatments might affect hormone levels and related health issues in patients.

To be eligible for the study, participants need to be over 18 years old, have a confirmed diagnosis of a specific type of blood cancer, and be in an advanced stage of their disease. They should also be receiving or be candidates for immune-checkpoint therapy. Participants will be asked to give their written consent to join the study. If you decide to participate, you will not be required to change your treatment plan, and your health will be monitored to gather information about any hormonal side effects that may arise. This study is currently looking for participants, and both men and women are welcome to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Retrospective cohort
• • patients aged\> 18 years
• • cyto-histological diagnosis of mature lymphoproliferative syndrome of B or T lymphocyte origin
• • advanced stage of illness (relapsed or refractory)
• • patients undergoing treatment with immune anticheckpoint antibodies.
• • written informed consent
• • Prospective cohort
• • patients aged\> 18 years
• • cyto-histological diagnosis of mature lymphoproliferative syndrome of B or T lymphocyte origin
• • advanced stage of illness (relapsed or refractory)
• • patients who are candidates for therapy with anticheckpoint immune antibodies (it is specified that this therapy is completely independent of the subject's participation in the study).
• • written informed consent
• Exclusion Criteria:
• • Severe, acute and chronic medical or psychiatric disorders that may affect the interpretation of the study results or interfere with it.