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

IRCCS Azienda Ospedaliero-Universitaria di Bologna100 enrolled

Overview

Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Hematological Malignancies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, Italy

RECRUITING

Outcomes

Primary Outcomes

Evaluate the incidence, type and severity of immune-related endocrine side effects

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.

Time frame: through study completion, an average of 2 years

Secondary Outcomes

search for predictive criteria for the appearance of immune-mediated endocrine toxicities

correlation between patients characteristics and occurrence of immune-mediated endocrine toxicities

Time frame: through study completion, an average of 2 year

impact of toxicity on the continuation of therapy

rate of patients who discontinued therapy due to toxicity

Time frame: through study completion, an average of 2 year

monitoring system for early diagnosis and management of toxicities

assesment of toxicities since first cycle and comparison with medical history

Time frame: through study completion, an average of 2 year

Central Contacts

Pier Luigi Zinzani, MD

CONTACT

+390512143680 pierluigi.zinzani@unibo.it

Cinzia Pellegrini, MD

CONTACT

+390512143680 cinzia.pellegrini@aosp.bo.it

Data from ClinicalTrials.gov

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