Towards Personalized Medicine for Refractory/Relapsed Follicular Lymphoma Patients: the Cantera/Lupiae Registry (LUPIAE)
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| ClinicalTrials.gov Identifier: NCT04587388 |
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Recruitment Status :
Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
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| Condition or disease |
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| Follicular Lymphoma Relapsed/Refractory Follicular Lymphoma |
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 In case a patient's eligibility is not confirmed and the patient is withdrawn from the study, the patient number will not be reused.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 [Patient Registry] |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | Towards Personalized Medicine for Refractory/Relapsed Follicular Lymphoma Patients: the Cantera/Lupiae Registry |
| Actual Study Start Date : | May 22, 2019 |
| Estimated Primary Completion Date : | May 22, 2023 |
| Estimated Study Completion Date : | May 22, 2026 |
- 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.
- Overall Survival (OS) [ Time Frame: 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) [ 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.
- 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.
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587388
| Contact: Sanne Tonino, MD | 020 56 64447 ext 0031 | hemat.trial@amc.nl | |
| Contact: Irene Dogliotti, MD | 3351732128 ext 0039 | irenedogl@hotmail.com |
| Croatia | |
| Klinički Bolnički Centar Split | Recruiting |
| Split, Croatia, 21000 | |
| Contact: Antonija Miljak, MD antonija.miljak003@gmail.com | |
| Italy | |
| AOU Città della Salute e della Scienza di Torino | Recruiting |
| Torino, Italy, 10126 | |
| Contact: Federica Cavallo, MD 0039 011 6334301 f.cavallo@unito.it | |
| Netherlands | |
| Academic Medical Center | Recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Contact: Sanne Tonino, MD 0031 020 56 64447 ext 28135 hemat.trial@amc.nl | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands, 9713 GZ | |
| Contact: Marcel Nijland, MD m.nijland@umcg.nl | |
| Portugal | |
| Instituto Português de Oncologia Francisco Gentil | Recruiting |
| Lisboa, Portugal | |
| Contact: Filipa Moita, MD filipamoita@gmail.com | |
| Spain | |
| Hospital Clinic de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Alfredo Rivas Delgado, MD 0034 93 227 45 31 ARIVAS@clinic.cat | |
| Hospital 12 de Octubre | Recruiting |
| Madrid, Spain, 28041 | |
| Contact: Ana Jimenez Ubieto, MD anitiju@hotmail.com | |
| Hospital Jose Maria Morales Meseguer | Recruiting |
| Murcia, Spain, 30008 | |
| Contact: José Javier Sanchez Blanco, MD josej.sanchez3@carm.es, | |
| Hospital de Son Llàtzer | Recruiting |
| Palma, Spain, 07198 | |
| Contact: Raquel del Campo Garcia, MD rcampo@hsll.es | |
| Hospital Universitario de Salamanca | Recruiting |
| Salamanca, Spain, 37007 | |
| Contact: Almudena Navarro Bailon, MD anavarrobailon@gmail.com | |
| Ukraine | |
| Kiev National Cancer Institute | Recruiting |
| Kiev, Ukraine, 03022 | |
| Contact: Iryna Kriachok, MD hematology@unci.org.ua | |
Publications:
| Responsible Party: | European Hematology Association - Lymphoma Group |
| ClinicalTrials.gov Identifier: | NCT04587388 |
| Other Study ID Numbers: |
W18_431 |
| First Posted: | October 14, 2020 Key Record Dates |
| Last Update Posted: | October 14, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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follicular lymphoma relapsed/refractory disease survival |
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Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |