Hematological Malignancies
Conditions
Keywords
immune-checkpoint inhibitors, endocrinological adverse events
Brief summary
Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the incidence, type and severity of immune-related endocrine side effects | through study completion, an average of 2 years | to evaluate the incidence, type and severity of immune-related endocrine side effects (thyroid disease, hypophysitis, diabetes) in patients treated with ICIs, through haematological-endocrinological management. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| search for predictive criteria for the appearance of immune-mediated endocrine toxicities | through study completion, an average of 2 year | correlation between patients characteristics and occurrence of immune-mediated endocrine toxicities |
| impact of toxicity on the continuation of therapy | through study completion, an average of 2 year | rate of patients who discontinued therapy due to toxicity |
| monitoring system for early diagnosis and management of toxicities | through study completion, an average of 2 year | assesment of toxicities since first cycle and comparison with medical history |
Countries
Italy
Contacts
Primary ContactPier Luigi Zinzani, MD
Backup ContactCinzia Pellegrini, MD
Outcome results
None listed