Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission

Hodgkin Lymphoma Clinical Trial

— HOLYFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298619
• Other study ID #: HEM-FEDII-HL follow-up -001
• Status: Completed
• Start date: June 2001
• Est. completion date: April 2019

Study information

• Verified date: March 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 2019
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High Risk
• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma
• Relapse

Intervention

Diagnostic Test:
• Standard cohort: Clinical lab follow-up

• Imaging cohort: integrated imaging follow-up

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival (EFS)	Events: refractoriness; relapse; death	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	EFS for clinically silent relapses	Events: refractoriness; relapse; death	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	Response rate	Rate of response	After salvage therapy and autologous stem cell transplantation (ASCT), up to 2 years