Clinical trial NCT06733987: Immunological Senescence Phenotype as a Resistance Profile to Pembrolizumab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Official title: Immunological Senescence Phenotype as a Resistance Profile to Pembrolizumab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hodgkin Lymphoma
Keywords: pembrolizumab
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population includes (R/R) cHL patients who receive a treatment with Pembrolizumab at the Unit of Hematology, IRCCS-Azienda Ospedaliero-Universitaria of Bologna

Brief summary: This is a single-centre, observational, prospective and exploratory study, which involves the use of human tissues from patients affected by Relapsed/Refractory classic Hodgkin Lymphoma treated with pembrolizumab at the Departmental Diagnosis and Therapy program for chronic lymphoproliferative syndromes of the IRCCS AOU of Bologna. Peripheral blood samples will be used for the study and will be taken:

* before starting treatment with pembrolizumab.
* undergoing therapy with pembrolizumab (cycle 2 (C2), C3, C4, C8, C12).

Detailed description: This is a single-centre, observational, prospective and exploratory study using human tissues from cHL R/R patients treated with pembrolizumab at the IRCCS AOU of Bologna's Diagnosis and Therapy of Chronic Lymphoproliferative Syndromes Departmental Programme. Peripheral blood samples will be used for the study

* before starting treatment with pembrolizumab.
* during pembrolizumab therapy (cycle 2 (C2), C3, C4, C8, C12). Patients who have achieved complete metabolic remission will continue pembrolizumab for two years without any consolidation therapy, while those who have achieved a partial response (after about 14-16 doses) will receive allo-transplantation.

Withdrawals will be performed according to clinical practice in accordance with the doctor's judgement. The diagnostic-therapeutic course of the patients will in no way be influenced by the outcome of the tissue examinations that will be carried out for the purposes of the study.

All patients with cHL R/R who are candidates for treatment with pembrolizumab as part of the normal care pathway at the IRCCS AOU of Bologna's Diagnosis and Treatment of Chronic Lymphoproliferative Syndromes Departmental Programme will be prospectively enrolled.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes aged ≥ 18 years at enrollment
* Patients affected by cHL R/R candidate to receive a treatment with Pembrolizumab
* Signature of informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: correlation between immunological profile of SIP and response to pembrolizumab
timeFrame: At the end of Cycle 2 (each cycle is 21 days)
Secondary outcomes:
measure: The correlation of cfDNA with response to therapy
timeFrame: during pembrolizumab therapy (cycle 2, 3, 4, 8 and12, each cycle is 21 days), through study completion, an average of 2 year
measure: The correlation of peculiar mutations with response to therapy
timeFrame: during pembrolizumab therapy (cycle 2, 3, 4, 8 and12, each cycle is 21 days), through study completion, an average of 2 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References: