Clinical trial NCT04587388: Towards Personalized Medicine for Refractory/Relapsed Follicular Lymphoma Patients: the Cantera/Lupiae Registry
Official title: Towards Personalized Medicine for Refractory/Relapsed Follicular Lymphoma Patients: the Cantera/Lupiae Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Follicular Lymphoma
Relapsed/Refractory Follicular Lymphoma
Keywords: follicular lymphoma
relapsed/refractory disease
survival
Lead sponsor: European Hematology Association - Lymphoma Group
Sponsor class: OTHER
Collaborators: name: Associazione Angela Serra per la ricerca sul cancro
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2020-10-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with initial diagnosis of follicular lymphoma, refractory/relapsed/transformed after first line therapy.

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.

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

Primary outcomes:
measure: Rate of Progression of disease within 24 months from start of second line treatment (second POD24)
timeFrame: 24 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 3 and 5 years
measure: Progression-free survival after second line therapy (second PFS)
timeFrame: 3 and 5 years
measure: Complete response rate at 30 months (CR30) from start of second line treatment (second CR30)
timeFrame: 30 months
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Klinički Bolnički Centar Split
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Lisboa
country: Portugal
facility: Instituto Português de Oncologia Francisco Gentil
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Murcia
country: Spain
facility: Hospital Jose Maria Morales Meseguer
city: Palma
country: Spain
facility: Hospital de Son Llàtzer
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Kiev
country: Ukraine
facility: Kiev National Cancer Institute
Study officials:
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