NCT06733987

Immunological Senescence Phenotype as a Resistance Profile to Pembrolizumab in Patients With Relapsed/Refractory Hodgkin's Lymphoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hodgkin Lymphoma

Timeline

• Start date: 2024-08-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2024-12-13
• Last updated: 2024-12-13

Locations

1 site across 1 country: Italy