Hodgkin Lymphoma Clinical Trial
— HOLYFUOfficial title:
Impact on Survival of Early Detection of Recurrence in the Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission
Verified date | March 2020 |
Source | Federico II University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
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 |
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