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

Last updated: October 8, 2020
Sponsor: European Hematology Association - Lymphoma Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Follicular Lymphoma

Lymphoproliferative Disorders

Lymphoma

Treatment

N/A

Clinical Study ID

NCT04587388
W18_431
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ondisease localization, laboratory parameters at staging, features of treatment adoptedand assurance of follow-up updating as requested

  • Diagnostic material available for review;

  • Written informed consent.

Exclusion

Exclusion Criteria:

• Age < 18 years

Study Design

Total Participants: 500
Study Start date:
May 22, 2019
Estimated Completion Date:
May 22, 2026

Study 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.

Connect with a study center

  • Klinički Bolnički Centar Split

    Split, 21000
    Croatia

    Active - Recruiting

  • AOU Città della Salute e della Scienza di Torino

    Torino, 10126
    Italy

    Active - Recruiting

  • Academic Medical Center

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • University Medical Center Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Instituto Português de Oncologia Francisco Gentil

    Lisboa,
    Portugal

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Jose Maria Morales Meseguer

    Murcia, 30008
    Spain

    Active - Recruiting

  • Hospital de Son Llàtzer

    Palma, 07198
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Kiev National Cancer Institute

    Kiev, 03022
    Ukraine

    Active - Recruiting

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