Immunological Senescence Phenotype as a Resistance Profile to Pembrolizumab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- correlation between immunological profile of SIP and response to pembrolizumab [Time frame: At the end of Cycle 2 (each cycle is 21 days)]
Secondary outcome measures (2)
- The correlation of cfDNA with response to therapy [Time frame: during pembrolizumab therapy (cycle 2, 3, 4, 8 and12, each cycle is 21 days), through study completion, an average of 2 year]
- The correlation of peculiar mutations with response to therapy [Time frame: during pembrolizumab therapy (cycle 2, 3, 4, 8 and12, each cycle is 21 days), through study completion, an average of 2 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06733987 · HL-SIP · funding number not available