Hodgkin LymphomaHOLYFUNCT04298619
Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission
An observational study of Hodgkin Lymphoma and High Risk, run by Federico II University.
Trial summary
Cohort study enrolled high-risk Hodgkin Lymphoma patients in first relapse after induction therapy followed after remission either with a systemic imaging-based surveillance (Imaging cohort) or with standard clinical-based surveillance (standard cohort). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, High Risk, Relapse
- What is being tested?
- Standard cohort: Clinical lab follow-up and Imaging cohort: integrated imaging follow-up
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Standard cohort: patients followed-up at the Santa Maria Loreto Mare Hospital Imaging cohort: patients followed-up at the University of Naples Federico II
Who may be able to join
- High risk Hodgkin Lymphoma
- achievement of complete response to first line therapy
Who cannot join
- comorbidities that could impair participation in follow-up procedures
About this study
Official title: Impact on Survival of Early Detection of Recurrence in the Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission
Cohort study enrolled high-risk Hodgkin Lymphoma patients in first relapse after induction therapy followed after remission either with a systemic imaging-based surveillance (Imaging cohort) or with standard clinical-based surveillance (standard cohort).
- Conditions
- Hodgkin Lymphoma, High Risk, Relapse
- Being tested
- Standard cohort: Clinical lab follow-up, Imaging cohort: integrated imaging follow-up
- Medical subject headings
- Hodgkin Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard cohort: Clinical lab follow-upDiagnostic test
Imaging cohort: integrated imaging follow-upDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Standard cohort | Clinical-based surveillance after first complete remission in High risk Hodgkin Lymphoma patients:
* symptom assessment
* blood tests
* physical examination Receives: Diagnostic Test: Standard cohort: Clinical lab follow-up | |
| Imaging cohort | Clinical-based surveillance after first complete remission in High risk Hodgkin Lymphoma patients:
* symptom assessment
* blood tests
* physical examination
* Positron Emission Tomography (PET)/Computed Tomography (CT) or Chest X-Ray ultrasonography scan of superficial, mediastinal, abdominal and pelvic lymph nodes Receives: Diagnostic Test: Standard cohort: Clinical lab follow-up; Diagnostic Test: Imaging cohort: integrated imaging follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival (EFS)
Events:
- refractoriness
- relapse
- death
Measured: Time period from the first relapse after induction therapy to the date of an event (refractoriness, relapse, or death) or the last follow-up visit after autologous stem cell transplantation (ASCT), up to 2 years
Secondary outcomes (2)
EFS for clinically silent relapses
Events:
- refractoriness
- relapse
- death
Measured: Time period from the first relapse after induction therapy to the date of an event (refractoriness, relapse, or death) or the last follow-up visit after autologous stem cell transplantation (ASCT), up to 2 years
Response rate
Rate of response
Measured: After salvage therapy and autologous stem cell transplantation (ASCT), up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study startJun 2001
- Primary completionApr 2016
- Study completionApr 2019
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 Federico II UniversityThe 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Picardi, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298619
- Sponsor's protocol ID
- HEM-FEDII-HL follow-up -001
- Acronym
- HOLYFU
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 6 Mar 2020
- 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 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Survival of Early Detection of Recurrence in the Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission
- ClinicalTrials.gov ID
- NCT04298619
- Acronym / sponsor ID
- HOLYFU / HEM-FEDII-HL follow-up -001
- Conditions
- Hodgkin Lymphoma, High Risk, Relapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jun 2001 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 6 Mar 2020 (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.
Cohort study enrolled high-risk Hodgkin Lymphoma patients in first relapse after induction therapy followed after remission either with a systemic imaging-based surveillance (Imaging cohort) or with standard clinical-based surveillance (standard cohort).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard cohort | – | Diagnostic Test: Standard cohort: Clinical lab follow-upClinical-based surveillance after first complete remission in High risk Hodgkin Lymphoma patients: * symptom assessment * blood tests * physical examination |
| Imaging cohort | – | Diagnostic Test: Standard cohort: Clinical lab follow-up, Diagnostic Test: Imaging cohort: integrated imaging follow-upClinical-based surveillance after first complete remission in High risk Hodgkin Lymphoma patients: * symptom assessment * blood tests * physical examination * Positron Emission Tomography (PET)/Computed Tomography (CT) or Chest X-Ray ultrasonography scan of superficial, mediastinal, abdominal and pelvic lymph nodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Standard cohort: patients followed-up at the Santa Maria Loreto Mare Hospital Imaging cohort: patients followed-up at the University of Naples Federico II
Key inclusion criteria (2 listed)
- High risk Hodgkin Lymphoma
- achievement of complete response to first line therapy
Key exclusion criteria (1 listed)
- comorbidities that could impair participation in follow-up procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard cohort: Clinical lab follow-up | Diagnostic test | Imaging cohort, Standard cohort |
| Imaging cohort: integrated imaging follow-up | Diagnostic test | Imaging cohort |
Primary outcome
Event Free Survival (EFS)
Time frame: Time period from the first relapse after induction therapy to the date of an event (refractoriness, relapse, or death) or the last follow-up visit after autologous stem cell transplantation (ASCT), up to 2 years
Events: * refractoriness * relapse * death
2 secondary outcomes
EFS for clinically silent relapses
Time frame: Time period from the first relapse after induction therapy to the date of an event (refractoriness, relapse, or death) or the last follow-up visit after autologous stem cell transplantation (ASCT), up to 2 years
Response rate
Time frame: After salvage therapy and autologous stem cell transplantation (ASCT), up to 2 years
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 6 Mar 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma and High Risk, run by Federico II University.
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 2 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 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Event Free Survival (EFS) (time frame: Time period from the first relapse after induction therapy to the date of an event (refractoriness, relapse, or death) or the last follow-up visit after autologous stem cell transplantation (ASCT), up to 2 years). 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 6 Mar 2020.