IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, 40138, Italy
Location status: Recruiting
Location contact
Beatrice Casadei, MD
CONTACT
Pier Luigi Zinzani, MD
CONTACT
Pier Luigi Zinzani, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06733987
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bologna, 40138, Italy
Location status: Recruiting
Beatrice Casadei, MD
CONTACT
Pier Luigi Zinzani, MD
CONTACT
Pier Luigi Zinzani, MD
PRINCIPAL_INVESTIGATOR
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Cytofluorimetric characterisation
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Beatrice Casadei, MD
CONTACT
Pier Luigi Zinzani, MD
CONTACT
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Acronym: HL-SIP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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