Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission

Completed

• Conditions: Hodgkin Lymphoma; Relapse; High Risk

• Registration Number: NCT04298619
• Lead Sponsor: Federico II University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2016-04
• Study Completion: 2019-04
• Status Verified: 2020-03
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-04
• Last Update Submitted: 2020-03-04
• Study First Posted: 2020-03-06
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event Free Survival (EFS)	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 Outcome Measures

Name	Time	Method
Response rate	After salvage therapy and autologous stem cell transplantation (ASCT), up to 2 years	Rate of response
EFS for clinically silent relapses	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