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

Recruiting

• Conditions: Classical Hodgkin Lymphoma

• Registration Number: NCT03552003
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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.

Study Timeline

• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-06-11
• Study Start: 2018-08-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-26
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OS	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 Outcome Measures

Name	Time	Method
PFS	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	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	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

Trial Locations

Locations (44)

SC Ematologia AO SS. Antonio e Biagio e C. Arrigo; 🇮🇹 Alessandria, Italy

Università Politecnica delle Marche - Clinica di Ematologia; 🇮🇹 Ancona, Italy

Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico; 🇮🇹 Avellino, Italy

Centro Riferimento Oncologico - S.O.C. Oncologia Medica A; 🇮🇹 Aviano, Italy

AOU Policlinico Consorziale - U.O. Ematologia con Trapianto; 🇮🇹 Bari, Italy

Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia; 🇮🇹 Barletta, Italy

ASST Spedali Civili di Brescia - Ematologia; 🇮🇹 Brescia, Italy

Ospedale Businco - Ematologia; 🇮🇹 Cagliari, Italy

Università Cattolica del Sacro Cuore - Ematologia; 🇮🇹 Campobasso, Italy

Ospedale di Castelfranco Veneto - Ematologia; 🇮🇹 Castelfranco Veneto, Italy

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