Mediastinal Grey Zone LymphomaNCT03037177
Mediastinal Grey Zone Lymphoma From the LYSA
An observational study of Mediastinal Grey Zone Lymphoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the literature. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mediastinal Grey Zone Lymphoma
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Jun 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We retrospectively identified cases treated in French, Belgium and Portuguese LYSA centers suspected to be MGZL using local pathological records, records from LYSA centers and the LYMPHOPATH network, which aims to review all newly diagnosed lymphoma cases in France (14). All the FFPE blocks and immunohistochemistry (IHC) slides (obtained prior any treatment) were centralized in the LYSA-Pathology (LYSA-P) department located in Henri Mondor hospital in Paris to perform a central review by a panel of hematopathologists. Two hundred and four cases were reviewed by the panel of LYSA hematopathologists.
Who may be able to join
- cases with an intermediate morphology and phenotype between CHL and PMBCL were included after central pathological review
Who cannot join
- Cases of CHL with partial CD20 expression or low expression in tumoral cells were excluded and considered as CD20-positive CHL
- Exclusion of sequential form patients (with a diagnostic biopsy of PMBCL and a relapse biopsy of CHL or vise-versa) as they represent a biases for statistical analysis.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hospitalier Lyon sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69126
About this study
Official title: Mediastinal Grey Zone Lymphoma: Clinico-pathological Characteristics and Outcomes of 99 Patients From the LYSA
Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the literature. Investigators report the clinical characteristics and outcomes of a large retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a consensus established for the diagnosis.
- Conditions
- Mediastinal Grey Zone Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHL like GZL | Classical Hodgkin Lymphoma like Grey Zone Lymphoma (morphology of CHL and phenotype of PMBCL) | |
| PMBCL like GZL | Primary Mediastinal B Cell Lymphoma like Grey Zone Lymphoma(morphology of PMBCL and phenotype of CHL) | |
| Composite | with a morphology of CHL on the one side and of PMBCL on the other side of the same diagnosis biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFS in the global population of GZL
Event-free survival (EFS) was calculated from the date of diagnosis to the date of progression, a change of therapy that was not initially scheduled (radiotherapy, high-dose therapy with autologous stem cell transplantation and other unplanned treatments) or death from any cause.
Measured: EFS: Event Free Survival from date of randomization until the date of first documented progression, up to 130 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal Grey Zone LymphomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037177
- Sponsor's protocol ID
- 69HCL16_0721
- Status last verified
- Oct 2016
- First submitted
- 4 Nov 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediastinal Grey Zone Lymphoma: Clinico-pathological Characteristics and Outcomes of 99 Patients From the LYSA
- ClinicalTrials.gov ID
- NCT03037177
- Acronym / sponsor ID
- 69HCL16_0721
- Conditions
- Mediastinal Grey Zone Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 31 Jan 2017 (estimated)
- 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.
Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the literature. Investigators report the clinical characteristics and outcomes of a large retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a consensus established for the diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHL like GZL | – | –Classical Hodgkin Lymphoma like Grey Zone Lymphoma (morphology of CHL and phenotype of PMBCL) |
| PMBCL like GZL | – | –Primary Mediastinal B Cell Lymphoma like Grey Zone Lymphoma(morphology of PMBCL and phenotype of CHL) |
| Composite | – | –with a morphology of CHL on the one side and of PMBCL on the other side of the same diagnosis biopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We retrospectively identified cases treated in French, Belgium and Portuguese LYSA centers suspected to be MGZL using local pathological records, records from LYSA centers and the LYMPHOPATH network, which aims to review all newly diagnosed lymphoma cases in France (14). All the FFPE blocks and immunohistochemistry (IHC) slides (obtained prior any treatment) were centralized in the LYSA-Pathology (LYSA-P) department located in Henri Mondor hospital in Paris to perform a central review by a panel of hematopathologists. Two hundred and four cases were reviewed by the panel of LYSA hematopathologists.
Key inclusion criteria (1 listed)
- cases with an intermediate morphology and phenotype between CHL and PMBCL were included after central pathological review
Key exclusion criteria (2 listed)
- Cases of CHL with partial CD20 expression or low expression in tumoral cells were excluded and considered as CD20-positive CHL
- Exclusion of sequential form patients (with a diagnostic biopsy of PMBCL and a relapse biopsy of CHL or vise-versa) as they represent a biases for statistical analysis.
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
EFS in the global population of GZL
Time frame: EFS: Event Free Survival from date of randomization until the date of first documented progression, up to 130 months
Event-free survival (EFS) was calculated from the date of diagnosis to the date of progression, a change of therapy that was not initially scheduled (radiotherapy, high-dose therapy with autologous stem cell transplantation and other unplanned treatments) or death from any cause.
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 31 Jan 2017.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Mediastinal Grey Zone Lymphoma, run by Hospices Civils de Lyon at 1 site in France.
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 2 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 31 Jan 2017. 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 France. 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?
EFS in the global population of GZL (time frame: EFS: Event Free Survival from date of randomization until the date of first documented progression, up to 130 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 31 Jan 2017.