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

Sponsor

European Hematology Association - Lymphoma Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT04587388

Collaborator

Associazione Angela Serra per la ricerca sul cancro (Other), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

500

Enrollment

Locations

Anticipated Duration (Months)

45.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma Relapsed/Refractory Follicular Lymphoma

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 In case a patient's eligibility is not confirmed and the patient is withdrawn from the study, the patient number will not be reused.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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 22, 2019

Anticipated Primary Completion Date :

May 22, 2023

Anticipated Study Completion Date :

May 22, 2026

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Klinički Bolnički Centar Split	Split	Croatia	21000
2	AOU Città della Salute e della Scienza di Torino	Torino	Italy	10126
3	Academic Medical Center	Amsterdam	Netherlands	1105 AZ
4	University Medical Center Groningen	Groningen	Netherlands	9713 GZ
5	Instituto Português de Oncologia Francisco Gentil	Lisboa	Portugal
6	Hospital Clinic de Barcelona	Barcelona	Spain	08036
7	Hospital 12 de Octubre	Madrid	Spain	28041
8	Hospital Jose Maria Morales Meseguer	Murcia	Spain	30008
9	Hospital de Son Llàtzer	Palma	Spain	07198
10	Hospital Universitario de Salamanca	Salamanca	Spain	37007
11	Kiev National Cancer Institute	Kiev	Ukraine	03022