Towards Personalized Medicine for Refractory/Relapsed Follicular Lymphoma Patients: the Cantera/Lupiae Registry

Recruiting

• Conditions: Relapsed/Refractory Follicular Lymphoma; Follicular Lymphoma

• Registration Number: NCT04587388
• Lead Sponsor: European Hematology Association - Lymphoma Group

Brief Summary

The optimal treatment strategy in patients with early progressive disease is not well known. In recent years, novel insights into the biology of Follicular Lymphoma (FL), and especially the role of the microenvironment, have resulted in the development of multiple novel treatment modalities. These new agents may ultimately improve the outlook for patients with FL with an unfavorable course, but for the development of the optimal therapeutic strategy, knowledge on the clinical and biological determinants of early refractory FL is needed.

Detailed Description

Patients with histologically confirmed follicular lymphoma are registered in the study at the time of the first event after first line treatment. An event is defined as refractory/relapsed disease documented by biopsy, imaging, or clinical evaluation. Registration is based on the locally established histological diagnosis, with exclusion of cases diagnosed on fine needle aspiration cytology, while tru-cut core-needle biopsies are permitted in the study. Registration will be done on-line on a key restricted accessible web-database: the Investigator must complete the on-line registration form after obtaining informed consent dated and signed by the patient.

Investigators are requested to register consecutive cases diagnosed at each participating Institution (all patients satisfying Inclusion criteria without any further selection). A patient number (Patient ID) will be assigned strictly sequentially in ascending order as patient's eligibility is verified. In case a patient's eligibility is not confirmed and the patient is withdrawn from the study, the patient number will not be reused. The assigned number will be used as the identification code for the subject.

Every registered case has to undergo histopathology review by a panel of experts. The reference pathologist will collect and review the pathology material sent by the participating centers, without knowledge of the clinical outcome of the patient. Both material obtained at diagnosis, and at relapse will be reviewed. Classification will be performed according to the World Health Organization recently published.

Study Timeline

• Study Start: 2019-05-22
• Status Verified: 2020-10
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-08
• Last Update Submitted: 2020-10-08
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14
• Primary Completion: 2023-05-22
• Study Completion: 2026-05-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients with initial diagnosis of follicular lymphoma, refractory/relapsed/transformed after first line therapy;
• All stages at the time of relapse;
• Histological grade 1-3a at the time of initial diagnosis;
• Age over 18 years;
• Availability of clinical data, including baseline information, comorbidities, data on disease localization, laboratory parameters at staging, features of treatment adopted and assurance of follow-up updating as requested
• Diagnostic material available for review;
• Written informed consent.

Exclusion Criteria

• Age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Progression of disease within 24 months from start of second line treatment (second POD24)	24 months	Second POD24 is defined as the rate of progression of disease at 24 months after the second line treatment.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	3 and 5 years	Overall Survival is measured from the date of diagnosis until death from any cause.
Progression-free survival after second line therapy (second PFS)	3 and 5 years	Second PFS is measured from the date of study entry until the date of disease progression or death from any cause.
Complete response rate at 30 months (CR30) from start of second line treatment (second CR30)	30 months	Second CR30 is defined as the rate of complete remissions at 30 months from start of second line treatment.

Trial Locations

Locations (11)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Klinički Bolnički Centar Split; 🇭🇷 Split, Croatia

Instituto Português de Oncologia Francisco Gentil; 🇵🇹 Lisboa, Portugal

Hospital de Son Llàtzer; 🇪🇸 Palma, Spain

AOU Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Italy

Hospital Jose Maria Morales Meseguer; 🇪🇸 Murcia, Spain

Kiev National Cancer Institute; 🇺🇦 Kiev, Ukraine

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain