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).

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Key information

Conditions

Hodgkin Lymphoma Disease Attributes Hemic and Lymphatic Diseases High Risk Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Relapse

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

High risk Hodgkin Lymphoma
achievement of complete response to first line therapy

Exclusion criteria

comorbidities that could impair participation in follow-up procedures

Treatment and study plan

Standard cohort: Clinical lab follow-up

Diagnostic Test

Imaging cohort: integrated imaging follow-up

Diagnostic Test

Primary outcomes

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

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
Events:
- refractoriness
- relapse
- death
Response rate

Time frame: After salvage therapy and autologous stem cell transplantation (ASCT), up to 2 years

Rate of response

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Impact on Survival of Early Detection of Recurrence in the Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission

Acronym: HOLYFU

Important dates

Study start: 2001
Primary completion: 2016
Study completion: 2019
First posted: Mar 6, 2020
Registry last updated: Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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