Study for Elderly (≥ 65 Years) Patients With Classical Hodgkin Lymphoma Undergoing CGA at Diagnosis

Overview

The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA)

Full Title of Study: “Prospective Study on Elderly (≥ 65 Years) Patients Affected With Classical Hodgkin Lymphoma Undergoing Comprehensive Geriatric Assessment at Diagnosis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2026

Detailed Description

The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA) Prospective data collection study of a consecutive series of newly diagnosed elderly cHL patients undergoing CGA before any therapy with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study. Patients will be screened and restaged according to clinical practice instrumental and laboratory assessments timing and type of examinations.

Interventions

  • Other: Treatment for clinical practise
    • Prospective data collection with the aim to to develop a prognostic index for elderly patients with newly diagnosed cHL

Arms, Groups and Cohorts

  • Newly diagnosed elderly cHL patients
    • Newly diagnosed elderly cHL patients undergoing CGA before any therapy (treatment for clinical practise) with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study

Clinical Trial Outcome Measures

Primary Measures

  • OS
    • Time Frame: June 2018-December 2025 (7.5 years)
    • Overall survival (OS). From the date of diagnosis to the date of last observation or death from any cause

Secondary Measures

  • PFS
    • Time Frame: June 2018-December 2025 (7.5 years)
    • Progression Free Survival (PFS): From the date of diagnosis to the last follow-up, or to one of the following events: disease progression during treatment, or relapse, or death from any cause.
  • FFS
    • Time Frame: June 2018-December 2025 (7.5 years)
    • Failure Free Survival (FFS). From the date of diagnosis to to any treatment failure including disease progression, or discontinuation of treatment for any reason, (eg, disease progression, toxicity, patient preference, initiation of new treatment), or death from any cause.
  • Response initial therapy
    • Time Frame: June 2018-January 2024 (5.5 years, 6-7 month after the enrolment)
    • Response initial therapy: Rate of complete remission (CR) after chemotherapy +/-RT, according to Cheson 2007

Participating in This Clinical Trial

Inclusion Criteria

1. Diagnosis of classical Hodgkin Lymphoma

2. Age ≥ 65 year

3. Evaluation of Comprehensive Geriatric Assessment at baseline

4. Signed informed consent

5. Previously untreated patients

Exclusion Criteria

None

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione Italiana Linfomi ONLUS
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vittorio Ruggero Zilioli, MD, Principal Investigator, SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda, Milano – Italy
  • Overall Contact(s)
    • Vittorio Ruggero Zilioli, MD, +39 02 64442668, vittorioruggero.zilioli@ospedaleniguarda.it

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