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

Prospective Study on Elderly (≥ 65 Years) Patients Affected With Classical Hodgkin Lymphoma Undergoing Comprehensive Geriatric Assessment at Diagnosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03552003
Enrollment
400
Registered
2018-06-11
Start date
2018-08-10
Completion date
2026-01-31
Last updated
2022-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Classical Hodgkin Lymphoma

Keywords

Hodgkin, Elderly patients, CGA

Brief summary

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)

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

OTHERTreatment for clinical practise

Prospective data collection with the aim to to develop a prognostic index for elderly patients with newly diagnosed cHL

Sponsors

Fondazione Italiana Linfomi - ETS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
OSJune 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

MeasureTime frameDescription
PFSJune 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.
FFSJune 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 therapyJune 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

Countries

Italy

Contacts

Primary ContactVittorio Ruggero Zilioli, MD
vittorioruggero.zilioli@ospedaleniguarda.it+39 02 64442668

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026