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

NCT06733987 | Recruiting

• 2 other identifiers: HL-SIPfunding number not available
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Hodgkin Lymphoma

Keywords

pembrolizumab

Outcome Measures

Primary Outcomes (1)

• correlation between immunological profile of SIP and response to pembrolizumab

  Cytofluorimetric characterisation

  At the end of Cycle 2 (each cycle is 21 days)

Secondary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The haematological and haematochemical examinations required by clinical practice for patients included in the study will be performed. Study-specific blood samples will be taken at the same time as the clinical practice samples. Cytofluorimetric and molecular investigations will be performed at the Laboratory of Transplantation Immunobiology and Advanced Cellular Therapies (IBT) of the IRCCS AOU of Bologna.

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pier Luigi Zinzani, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Luigi Zinzani, MD

CONTACT

+390512144042; pierluigi.zinzani@unibo.it

Beatrice Casadei, MD

CONTACT

+390512144042; beatrice.casadei@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 13, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)