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

NCT ID: NCT04587388

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-22
• Study Completion Date: 2026-05-22

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 In case a patient's eligibility is not confirmed and the patient is withdrawn from the study, the patient number will not be reused.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.

Conditions

Follicular Lymphoma; Relapsed/Refractory Follicular Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associazione Angela Serra per la ricerca sul cancro

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

European Hematology Association - Lymphoma Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klinički Bolnički Centar Split

Split, , Croatia

Site Status: RECRUITING

AOU Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status: RECRUITING

Academic Medical Center

Amsterdam, , Netherlands

Site Status: RECRUITING

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Instituto Português de Oncologia Francisco Gentil

Lisbon, , Portugal

Site Status: RECRUITING

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Hospital 12 de Octubre

Madrid, , Spain

Site Status: RECRUITING

Hospital Jose Maria Morales Meseguer

Murcia, , Spain

Site Status: RECRUITING

Hospital de Son Llàtzer

Palma, , Spain

Site Status: RECRUITING

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status: RECRUITING

Kiev National Cancer Institute

Kiev, , Ukraine

Site Status: RECRUITING

Countries

Croatia; Italy; Netherlands; Portugal; Spain; Ukraine

Central Contacts

Sanne Tonino, MD

Role: CONTACT

hemat.trial@amc.nl

020 56 64447 ext. 0031

Irene Dogliotti, MD

Role: CONTACT

irenedogl@hotmail.com

3351732128 ext. 0039

Facility Contacts

Antonija Miljak, MD

Role: primary

antonija.miljak003@gmail.com

Federica Cavallo, MD

Role: primary

f.cavallo@unito.it

0039 011 6334301

Sanne Tonino, MD

Role: primary

hemat.trial@amc.nl

0031 020 56 64447 ext. 28135

Marcel Nijland, MD

Role: primary

m.nijland@umcg.nl

Filipa Moita, MD

Role: primary

filipamoita@gmail.com

Alfredo Rivas Delgado, MD

Role: primary

ARIVAS@clinic.cat

0034 93 227 45 31

Ana Jimenez Ubieto, MD

Role: primary

anitiju@hotmail.com

José Javier Sanchez Blanco, MD

Role: primary

josej.sanchez3@carm.es,

Raquel del Campo Garcia, MD

Role: primary

rcampo@hsll.es

Almudena Navarro Bailon, MD

Role: primary

anavarrobailon@gmail.com

Iryna Kriachok, MD

Role: primary

hematology@unci.org.ua

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Other Identifiers

W18_431

Identifier Type: -

Identifier Source: org_study_id