Immunological Senescence Phenotype as a Resistance Profile to Pembrolizumab in Patients With Relapsed/Refractory Hodgkin's Lymphoma (HL-SIP)

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).

Study Overview

• Status: Recruiting
• Conditions: Hodgkin Lymphoma

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Pier Luigi Zinzani, MD; Phone Number: +390512144042; Email: pierluigi.zinzani@unibo.it
• Study Contact Backup: Name: Beatrice Casadei, MD; Phone Number: +390512144042; Email: beatrice.casadei@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna
    • Principal Investigator: Pier Luigi Zinzani, MD
    • Contact: Pier Luigi Zinzani, MD; Phone Number: +390512144042; Email: pierluigi.zinzani@unibo.it
    • Contact: Beatrice Casadei, MD; Phone Number: +390512143680; Email: beatrice.casadei@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between immunological profile of SIP and response to pembrolizumab	Cytofluorimetric characterisation	At the end of Cycle 2 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation of cfDNA with response to therapy	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	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	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	during pembrolizumab therapy (cycle 2, 3, 4, 8 and12, each cycle is 21 days), through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Estimated): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: pembrolizumab
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease
• Other Study ID Numbers: HL-SIP; funding number not available (Other Grant/Funding Number: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No