Trials Sponsors Conditions Drugs Pricing

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Otherlead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Pier Luigi Zinzani, MDCONTACT+390512144042 pierluigi.zinzani@unibo.it

Beatrice Casadei, MDCONTACT+390512143680 beatrice.casadei@aosp.bo.it

Pier Luigi Zinzani, MDPRINCIPAL INVESTIGATOR

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)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune 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

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

Actual (reported)

Primary Completion

February 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations