Hodgkin Lymphoma
Conditions
Keywords
pembrolizumab
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| correlation between immunological profile of SIP and response to pembrolizumab | At the end of Cycle 2 (each cycle is 21 days) | Cytofluorimetric characterisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The correlation of cfDNA with response to therapy | during pembrolizumab therapy (cycle 2, 3, 4, 8 and12, each cycle is 21 days), through study completion, an average of 2 year | Clinical response: absence of clinical signs and symptoms of disease according to international criteria (Cheson et al 2007) and assessed by PET/CT examination. Metabolic response: negative uptake in PET/CT or Deauville scale \<3 |
| The correlation of peculiar mutations with response to therapy | during pembrolizumab therapy (cycle 2, 3, 4, 8 and12, each cycle is 21 days), through study completion, an average of 2 year | Clinical response: absence of clinical signs and symptoms of disease according to international criteria (Cheson et al 2007) and assessed by PET/CT examination. Metabolic response: negative uptake in PET/CT or Deauville scale \<3 |
Countries
Italy
Contacts
Primary ContactPier Luigi Zinzani, MD
Backup ContactBeatrice Casadei, MD
Outcome results
None listed