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

October 8, 2020 updated by: European Hematology Association - Lymphoma Group
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.

Study Overview

Status

Recruiting

Conditions

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 In case a patient's eligibility is not confirmed and the patient is withdrawn from the study, the patient number will not be reused.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

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Croatia
  • Italy
      • Torino, Italy, 10126
        • Recruiting
        • AOU Città della Salute e della Scienza di Torino
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Recruiting
        • Academic Medical Center
        • Contact:
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen
        • Contact:
  • Portugal
      • Lisboa, Portugal
        • Recruiting
        • Instituto Portugues de Oncologia Francisco Gentil
        • Contact:
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
      • Madrid, Spain, 28041
      • Murcia, Spain, 30008
        • Recruiting
        • Hospital Jose Maria Morales Meseguer
        • Contact:
      • Palma, Spain, 07198
        • Recruiting
        • Hospital de Son Llàtzer
        • Contact:
      • Salamanca, Spain, 37007
  • Ukraine
      • Kiev, Ukraine, 03022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Progression of disease within 24 months from start of second line treatment (second POD24)
Time Frame: 24 months
Second POD24 is defined as the rate of progression of disease at 24 months after the second line treatment.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 3 and 5 years
Overall Survival is measured from the date of diagnosis until death from any cause.
3 and 5 years
Progression-free survival after second line therapy (second PFS)
Time Frame: 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.
3 and 5 years
Complete response rate at 30 months (CR30) from start of second line treatment (second CR30)
Time Frame: 30 months
Second CR30 is defined as the rate of complete remissions at 30 months from start of second line treatment.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Hematology Association - Lymphoma Group

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 22, 2019

Primary Completion (ANTICIPATED)

May 22, 2023

Study Completion (ANTICIPATED)

May 22, 2026

Study Registration Dates

First Submitted

October 8, 2020

First Submitted That Met QC Criteria

October 8, 2020

First Posted (ACTUAL)

October 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W18_431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share with other involved researchers the minimum information on IPD for publication.

It is responsibility of the Study Coordinators to publish the study results after the completion of the study. It will be ensured that the data from one center are not published before the publication of the whole study. All publications regarding the results of the study will be marked with the sentence "on behalf of the EHA-LyG/Cantera-Lupiae study group". Participating centers and sites will be mentioned according to their overall contribution to the study, while all members of the study group will be included as authors of the manuscripts for their active contribution on the study design and procedures. No publication can occur without agreement of the study sponsor. Study results will be submitted for publication in peer-reviewed journals and for presentation at appropriate scientific meetings and conferences.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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