Classical Hodgkin LymphomaLH2004MENCT06814860
Microenvironmental Trial of Classical Hodgkin Lymphoma in Adolescents
An observational study of Classical Hodgkin Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Background. Classical Hodgkin's lymphoma (cHL) in adolescents between 15 and 18 years shows a higher disease-related mortality and the overall prognosis is worse than both children and adults. Objectives. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Classical Hodgkin Lymphoma
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 7 Feb 2024to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged 12 to 18 years who were histologically diagnosed with Classical Hodgkin lymphoma between 01/01/1996 and 31/12/2020 will be enrolled in the study.
Who may be able to join
- Patients aged 12 to 18 years at diagnosis of Classical Hodgkin lymphoma.
Who cannot join
- Unavailability/insufficiency of histological material for diagnosis.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
About this study
Background. Classical Hodgkin's lymphoma (cHL) in adolescents between 15 and 18 years shows a higher disease-related mortality and the overall prognosis is worse than both children and adults.
Objectives. To investigate the immune checkpoint inhibitors (ICPI) therapeutic targets and specific T-regulatory and cytotoxic T-cell subsets, in the subgroup of adolescent cHL patients and to investigate their prognostic power.
Methods: Retrieved formalin-fixed paraffin-embedded (FFPE) of adolescent patients diagnosed with cHL with available clinical and tested by immunohistochemistry the immune checkpoint molecules CTLA-4, LAG-3, PD-1 and PDL1 and the biological markers FOXP3 and CD8.
- Conditions
- Classical Hodgkin Lymphoma
- Keywords
- Hodgkin Lymphoma, adolescent, microenvironment, immune-check points
- Medical subject headings
- Hodgkin Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the tumour microenvironment
Identification of phenotypic markers with possible prognostic and/or therapeutic impact predictive of clinical outcomes in patients undergoing LHC in pediatric/adolescent age.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start7 Feb 2024
- Primary completion23 May 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical 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
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Sabattini, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814860
- Sponsor's protocol ID
- LH2004ME
- Other IDs
- RC-2022-2773380
- Acronym
- LH2004ME
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microenvironmental Trial of Classical Hodgkin Lymphoma in Adolescents
- ClinicalTrials.gov ID
- NCT06814860
- Acronym / sponsor ID
- LH2004ME / LH2004ME
- Conditions
- Classical Hodgkin Lymphoma
- Keywords
- Hodgkin Lymphoma, adolescent, microenvironment, immune-check points
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 7 Feb 2025 (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.
Background. Classical Hodgkin's lymphoma (cHL) in adolescents between 15 and 18 years shows a higher disease-related mortality and the overall prognosis is worse than both children and adults.
Objectives. To investigate the immune checkpoint inhibitors (ICPI) therapeutic targets and specific T-regulatory and cytotoxic T-cell subsets, in the subgroup of adolescent cHL patients and to investigate their prognostic power.
Methods: Retrieved formalin-fixed paraffin-embedded (FFPE) of adolescent patients diagnosed with cHL with available clinical and tested by immunohistochemistry the immune checkpoint molecules CTLA-4, LAG-3, PD-1 and PDL1 and the biological markers FOXP3 and CD8.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 12 to 18 years who were histologically diagnosed with Classical Hodgkin lymphoma between 01/01/1996 and 31/12/2020 will be enrolled in the study.
Key inclusion criteria (1 listed)
- Patients aged 12 to 18 years at diagnosis of Classical Hodgkin lymphoma.
Key exclusion criteria (1 listed)
- Unavailability/insufficiency of histological material for diagnosis.
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
Characterization of the tumour microenvironment
Time frame: through study completion, an average of 3 months
Identification of phenotypic markers with possible prognostic and/or therapeutic impact predictive of clinical outcomes in patients undergoing LHC in pediatric/adolescent age.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
Related trials for Classical Hodgkin Lymphoma
RecruitingPhase 3
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
Active, not recruitingPhase 2
Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)
Hodgkin Lymphoma
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
Active, not recruitingPhase 3
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma
RecruitingPhase 1/2
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Hodgkin Lymphoma
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. This study is not recruiting at the moment.
Elena Sabattini, 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 Classical 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 1 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: finished, as of the sponsor's last update on 7 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the tumour microenvironment (time frame: through study completion, an average of 3 months). 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 7 Feb 2025.