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

NCT04587388 | Recruiting

• 1 other identifier: W18_431
• Study Type: observational
• Target: 500
• Locations: 6 countries
• Sites: 11

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.

Conditions

Follicular Lymphoma; Relapsed/Refractory Follicular Lymphoma

Keywords

follicular lymphoma; relapsed/refractory disease; survival

Outcome Measures

Primary Outcomes (1)

• Rate of Progression of disease within 24 months from start of second line treatment (second POD24)

  Second POD24 is defined as the rate of progression of disease at 24 months after the second line treatment.

  24 months

Secondary Outcomes (3)

• Overall Survival (OS)

  3 and 5 years

• Progression-free survival after second line therapy (second PFS)

  3 and 5 years

• Complete response rate at 30 months (CR30) from start of second line treatment (second CR30)

  30 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with initial diagnosis of follicular lymphoma, refractory/relapsed/transformed after first line therapy.

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• European Hematology Association - Lymphoma Group: lead
• Associazione Angela Serra per la ricerca sul cancro: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (11)

Klinički Bolnički Centar Split

Split, 21000, Croatia

RECRUITING

AOU Città della Salute e della Scienza di Torino

Torino, 10126, Italy

RECRUITING

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Instituto Português de Oncologia Francisco Gentil

Lisbon, Portugal

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Jose Maria Morales Meseguer

Murcia, 30008, Spain

RECRUITING

Hospital de Son Llàtzer

Palma, 07198, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Kiev National Cancer Institute

Kiev, 03022, Ukraine

RECRUITING

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Histological block or slides for confirming the diagnosis. This analysis will be conducted retrospectively.

MeSH Terms

Conditions

Lymphoma, Follicular; Disease

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sanne Tonino, MD

CONTACT

020 56 64447; hemat.trial@amc.nl

Irene Dogliotti, MD

CONTACT

3351732128; irenedogl@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 14, 2020
• Study Start: May 22, 2019
• Primary Completion: May 22, 2023
• Study Completion (Estimated): May 22, 2026
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Preliminary analysis results will be made available during the study. Final results will be made available 6-12 months after the end of the study.

Locations

ES (5); CR (1); IT (1); NL (2); UA (1); PT (1)