Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission

NCT04298619 | Completed

• 1 other identifier: HEM-FEDII-HL follow-up -001
• Study Type: observational
• Target: 123
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hodgkin Lymphoma; High Risk; Relapse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Response rate

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

Study Arms (2)

Standard cohort

Clinical-based surveillance after first complete remission in High risk Hodgkin Lymphoma patients: * symptom assessment * blood tests * physical examination

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

Diagnostic Test: Standard cohort: Clinical lab follow-up; Diagnostic Test: Imaging cohort: integrated imaging follow-up

Interventions

Standard cohort: Clinical lab follow-up DIAGNOSTIC_TEST

Imaging cohort; Standard cohort

Imaging cohort: integrated imaging follow-up DIAGNOSTIC_TEST

Imaging cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

You may not qualify if:

• comorbidities that could impair participation in follow-up procedures

Sponsors & Collaborators

• Federico II University: lead

MeSH Terms

Conditions

Hodgkin Disease; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 6, 2020
• Study Start: June 1, 2001
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2019
• Last Updated: March 6, 2020

Record last verified: 2020-03