Hodgkin LymphomaHL-SIPNCT06733987
Immunological Senescence Phenotype as a Resistance Profile to Pembrolizumab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
An observational study of Hodgkin Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2024to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, 40138
Pier Luigi Zinzani, MD, +390512144042, pierluigi.zinzani@unibo.it
Beatrice Casadei, MD, +390512143680, beatrice.casadei@aosp.bo.it
About this study
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).
Read the 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
- Keywords
- pembrolizumab
- Medical subject headings
- Hodgkin Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between immunological profile of SIP and response to pembrolizumab
Cytofluorimetric characterisation
Measured: At the end of Cycle 2 (each cycle is 21 days)
Secondary outcomes (2)
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
Measured: 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
Measured: during pembrolizumab therapy (cycle 2, 3, 4, 8 and12, each cycle is 21 days), through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Aug 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Luigi Zinzani, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733987
- Sponsor's protocol ID
- HL-SIP
- Other IDs
- funding number not available
- Acronym
- HL-SIP
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Senescence Phenotype as a Resistance Profile to Pembrolizumab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT06733987
- Acronym / sponsor ID
- HL-SIP / HL-SIP
- Conditions
- Hodgkin Lymphoma
- Keywords
- pembrolizumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between immunological profile of SIP and response to pembrolizumab
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Cytofluorimetric characterisation
2 secondary outcomes
The correlation of cfDNA with response to therapy
Time frame: 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
Time frame: during pembrolizumab therapy (cycle 2, 3, 4, 8 and12, each cycle is 21 days), through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pier Luigi Zinzani, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pier Luigi Zinzani, MD (+390512144042, pierluigi.zinzani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between immunological profile of SIP and response to pembrolizumab (time frame: At the end of Cycle 2 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.