Follicular LymphomaLUPIAENCT04587388
Towards Personalized Medicine for Refractory/Relapsed Follicular Lymphoma Patients: the Cantera/Lupiae Registry
An observational study of Follicular Lymphoma and Relapsed/Refractory Follicular Lymphoma, run by European Hematology Association - Lymphoma Group at 11 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, Relapsed/Refractory Follicular Lymphoma
- How many people
- 500 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 22 May 2019to 22 May 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with initial diagnosis of follicular lymphoma, refractory/relapsed/transformed after first line therapy.
Who may be able to join
- 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.
Who cannot join
- Age < 18 years
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
Spain5 sites, 5 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Alfredo Rivas Delgado, MD, 0034 93 227 45 31, ARIVAS@clinic.cat
- Recruiting
Hospital 12 de Octubre
Madrid, 28041
Ana Jimenez Ubieto, MD, anitiju@hotmail.com
- Recruiting
Hospital Jose Maria Morales Meseguer
Murcia, 30008
José Javier Sanchez Blanco, MD, josej.sanchez3@carm.es,
- Recruiting
Hospital de Son Llàtzer
Palma, 07198
Raquel del Campo Garcia, MD, rcampo@hsll.es
- Recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
Almudena Navarro Bailon, MD, anavarrobailon@gmail.com
Netherlands2 sites, 2 recruiting
- Recruiting
Academic Medical Center
Amsterdam, 1105 AZ
Sanne Tonino, MD, 0031 020 56 64447 ext. 28135, hemat.trial@amc.nl
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Marcel Nijland, MD, m.nijland@umcg.nl
Croatia1 site, 1 recruiting
- Recruiting
Klinički Bolnički Centar Split
Split, 21000
Antonija Miljak, MD, antonija.miljak003@gmail.com
Italy1 site, 1 recruiting
- Recruiting
AOU Città della Salute e della Scienza di Torino
Torino, 10126
Federica Cavallo, MD, 0039 011 6334301, f.cavallo@unito.it
Portugal1 site, 1 recruiting
- Recruiting
Instituto Português de Oncologia Francisco Gentil
Lisbon
Filipa Moita, MD, filipamoita@gmail.com
Ukraine1 site, 1 recruiting
- Recruiting
Kiev National Cancer Institute
Kiev, 03022
Iryna Kriachok, MD, hematology@unci.org.ua
About this study
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.
Read the 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.
- Keywords
- follicular lymphoma, relapsed/refractory disease, survival
- Medical subject headings
- Lymphoma, Follicular, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (3)
Overall Survival (OS)
Overall Survival is measured from the date of diagnosis until death from any cause.
Measured: 3 and 5 years
Progression-free survival after second line therapy (second PFS)
Second PFS is measured from the date of study entry until the date of disease progression or death from any cause.
Measured: 3 and 5 years
Complete response rate at 30 months (CR30) from start of second line treatment (second CR30)
Second CR30 is defined as the rate of complete remissions at 30 months from start of second line treatment.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start22 May 2019
- Primary completion22 May 2023 (estimated)
- Study completion22 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- European Hematology Association - Lymphoma Group
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Angela Serra per la ricerca sul cancro, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587388
- Sponsor's protocol ID
- W18_431
- Acronym
- LUPIAE
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Zelenetz AD, Gordon LI, Wierda WG, Abramson JS, Advani RH, Andreadis CB, Bartlett N, Byrd JC, Czuczman MS, Fayad LE, Fisher RI, Glenn MJ, Harris NL, Hoppe RT, Horwitz SM, Kelsey CR, Kim YH, Krivacic S, LaCasce AS, Nademanee A, Porcu P, Press O, Rabinovitch R, Reddy N, Reid E, Saad AA, Sokol L, Swinnen LJ, Tsien C, Vose JM, Yahalom J, Zafar N, Dwyer M, Sundar H; National comprehensive cancer network. Non-Hodgkin's lymphomas, version 4.2014. J Natl Compr Canc Netw. 2014 Sep;12(9):1282-303. doi: 10.6004/jnccn.2014.0125.
PubMed 25190696Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.
PubMed 26980727Mounier M, Bossard N, Remontet L, Belot A, Minicozzi P, De Angelis R, Capocaccia R, Iwaz J, Monnereau A, Troussard X, Sant M, Maynadie M, Giorgi R; EUROCARE-5 Working Group; CENSUR Working Survival Group. Changes in dynamics of excess mortality rates and net survival after diagnosis of follicular lymphoma or diffuse large B-cell lymphoma: comparison between European population-based data (EUROCARE-5). Lancet Haematol. 2015 Nov;2(11):e481-91. doi: 10.1016/S2352-3026(15)00155-6. Epub 2015 Oct 23.
PubMed 26686258Luminari S, Cesaretti M, Rashid I, Mammi C, Montanini A, Barbolini E, Bellei M, Pennese E, Sirotti MA, Marcheselli L, Partesotti G, Bari A, Maiorana A, Bonacorsi G, Federico M. Incidence, clinical characteristics and survival of malignant lymphomas: a population-based study from a cancer registry in northern Italy. Hematol Oncol. 2007 Dec;25(4):189-97. doi: 10.1002/hon.826.
PubMed 17654762Leich E, Ott G, Rosenwald A. Pathology, pathogenesis and molecular genetics of follicular NHL. Best Pract Res Clin Haematol. 2011 Jun;24(2):95-109. doi: 10.1016/j.beha.2011.02.003. Epub 2011 Apr 7.
PubMed 21658611de Jong D. Molecular pathogenesis of follicular lymphoma: a cross talk of genetic and immunologic factors. J Clin Oncol. 2005 Sep 10;23(26):6358-63. doi: 10.1200/JCO.2005.26.856.
PubMed 16155020Kuppers R. Mechanisms of B-cell lymphoma pathogenesis. Nat Rev Cancer. 2005 Apr;5(4):251-62. doi: 10.1038/nrc1589.
PubMed 15803153Kridel R, Sehn LH, Gascoyne RD. Pathogenesis of follicular lymphoma. J Clin Invest. 2012 Oct;122(10):3424-31. doi: 10.1172/JCI63186. Epub 2012 Oct 1.
PubMed 23023713Lossos IS, Gascoyne RD. Transformation of follicular lymphoma. Best Pract Res Clin Haematol. 2011 Jun;24(2):147-63. doi: 10.1016/j.beha.2011.02.006. Epub 2011 May 6.
PubMed 21658615Rowley JD. Chromosome studies in the non-Hodgkin's lymphomas: the role of the 14;18 translocation. J Clin Oncol. 1988 May;6(5):919-25. doi: 10.1200/JCO.1988.6.5.919.
PubMed 3284977Okosun J, Bodor C, Wang J, Araf S, Yang CY, Pan C, Boller S, Cittaro D, Bozek M, Iqbal S, Matthews J, Wrench D, Marzec J, Tawana K, Popov N, O'Riain C, O'Shea D, Carlotti E, Davies A, Lawrie CH, Matolcsy A, Calaminici M, Norton A, Byers RJ, Mein C, Stupka E, Lister TA, Lenz G, Montoto S, Gribben JG, Fan Y, Grosschedl R, Chelala C, Fitzgibbon J. Integrated genomic analysis identifies recurrent mutations and evolution patterns driving the initiation and progression of follicular lymphoma. Nat Genet. 2014 Feb;46(2):176-181. doi: 10.1038/ng.2856. Epub 2013 Dec 22.
PubMed 24362818Tan D, Horning SJ, Hoppe RT, Levy R, Rosenberg SA, Sigal BM, Warnke RA, Natkunam Y, Han SS, Yuen A, Plevritis SK, Advani RH. Improvements in observed and relative survival in follicular grade 1-2 lymphoma during 4 decades: the Stanford University experience. Blood. 2013 Aug 8;122(6):981-7. doi: 10.1182/blood-2013-03-491514. Epub 2013 Jun 18.
PubMed 23777769Bastion Y, Sebban C, Berger F, Felman P, Salles G, Dumontet C, Bryon PA, Coiffier B. Incidence, predictive factors, and outcome of lymphoma transformation in follicular lymphoma patients. J Clin Oncol. 1997 Apr;15(4):1587-94. doi: 10.1200/JCO.1997.15.4.1587.
PubMed 9193357Solal-Celigny P, Roy P, Colombat P, White J, Armitage JO, Arranz-Saez R, Au WY, Bellei M, Brice P, Caballero D, Coiffier B, Conde-Garcia E, Doyen C, Federico M, Fisher RI, Garcia-Conde JF, Guglielmi C, Hagenbeek A, Haioun C, LeBlanc M, Lister AT, Lopez-Guillermo A, McLaughlin P, Milpied N, Morel P, Mounier N, Proctor SJ, Rohatiner A, Smith P, Soubeyran P, Tilly H, Vitolo U, Zinzani PL, Zucca E, Montserrat E. Follicular lymphoma international prognostic index. Blood. 2004 Sep 1;104(5):1258-65. doi: 10.1182/blood-2003-12-4434. Epub 2004 May 4.
PubMed 15126323Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Pileri S, Pulsoni A, Soubeyran P, Cortelazzo S, Martinelli G, Martelli M, Rigacci L, Arcaini L, Di Raimondo F, Merli F, Sabattini E, McLaughlin P, Solal-Celigny P. Follicular lymphoma international prognostic index 2: a new prognostic index for follicular lymphoma developed by the international follicular lymphoma prognostic factor project. J Clin Oncol. 2009 Sep 20;27(27):4555-62. doi: 10.1200/JCO.2008.21.3991. Epub 2009 Aug 3.
PubMed 19652063
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Personalized Medicine for Refractory/Relapsed Follicular Lymphoma Patients: the Cantera/Lupiae Registry
- ClinicalTrials.gov ID
- NCT04587388
- Acronym / sponsor ID
- LUPIAE / W18_431
- Keywords
- follicular lymphoma, relapsed/refractory disease, survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- European Hematology Association - Lymphoma GroupUniversity, hospital or other
- Collaborators
- Associazione Angela Serra per la ricerca sul cancro, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 22 May 2019 (actual)
- Primary completion
- 22 May 2023 (estimated)
- Study completion
- 22 May 2026 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with initial diagnosis of follicular lymphoma, refractory/relapsed/transformed after first line therapy.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Overall Survival (OS)
Time frame: 3 and 5 years
Progression-free survival after second line therapy (second PFS)
Time frame: 3 and 5 years
Complete response rate at 30 months (CR30) from start of second line treatment (second CR30)
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 25190696Zelenetz AD, Gordon LI, Wierda WG, Abramson JS, Advani RH, Andreadis CB, Bartlett N, Byrd JC, Czuczman MS, Fayad LE, Fisher RI, Glenn MJ, Harris NL, Hoppe RT, Horwitz SM, Kelsey CR, Kim YH, Krivacic S, LaCasce AS, Nademanee A, Porcu P, Press O, Rabinovitch R, Reddy N, Reid E, Saad AA, Sokol L, Swinnen LJ, Tsien C, Vose JM, Yahalom J, Zafar N, Dwyer M, Sundar H; National comprehensive cancer network. Non-Hodgkin's lymphomas, version 4.2014. J Natl Compr Canc Netw. 2014 Sep;12(9):1282-303. doi: 10.6004/jnccn.2014.0125.
- Background: PubMed 26980727Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.
- Background: PubMed 26686258Mounier M, Bossard N, Remontet L, Belot A, Minicozzi P, De Angelis R, Capocaccia R, Iwaz J, Monnereau A, Troussard X, Sant M, Maynadie M, Giorgi R; EUROCARE-5 Working Group; CENSUR Working Survival Group. Changes in dynamics of excess mortality rates and net survival after diagnosis of follicular lymphoma or diffuse large B-cell lymphoma: comparison between European population-based data (EUROCARE-5). Lancet Haematol. 2015 Nov;2(11):e481-91. doi: 10.1016/S2352-3026(15)00155-6. Epub 2015 Oct 23.
- Background: PubMed 17654762Luminari S, Cesaretti M, Rashid I, Mammi C, Montanini A, Barbolini E, Bellei M, Pennese E, Sirotti MA, Marcheselli L, Partesotti G, Bari A, Maiorana A, Bonacorsi G, Federico M. Incidence, clinical characteristics and survival of malignant lymphomas: a population-based study from a cancer registry in northern Italy. Hematol Oncol. 2007 Dec;25(4):189-97. doi: 10.1002/hon.826.
- Background: PubMed 21658611Leich E, Ott G, Rosenwald A. Pathology, pathogenesis and molecular genetics of follicular NHL. Best Pract Res Clin Haematol. 2011 Jun;24(2):95-109. doi: 10.1016/j.beha.2011.02.003. Epub 2011 Apr 7.
- Background: PubMed 16155020de Jong D. Molecular pathogenesis of follicular lymphoma: a cross talk of genetic and immunologic factors. J Clin Oncol. 2005 Sep 10;23(26):6358-63. doi: 10.1200/JCO.2005.26.856.
- Background: PubMed 15803153Kuppers R. Mechanisms of B-cell lymphoma pathogenesis. Nat Rev Cancer. 2005 Apr;5(4):251-62. doi: 10.1038/nrc1589.
- Background: PubMed 23023713Kridel R, Sehn LH, Gascoyne RD. Pathogenesis of follicular lymphoma. J Clin Invest. 2012 Oct;122(10):3424-31. doi: 10.1172/JCI63186. Epub 2012 Oct 1.
- Background: PubMed 21658615Lossos IS, Gascoyne RD. Transformation of follicular lymphoma. Best Pract Res Clin Haematol. 2011 Jun;24(2):147-63. doi: 10.1016/j.beha.2011.02.006. Epub 2011 May 6.
- Background: PubMed 3284977Rowley JD. Chromosome studies in the non-Hodgkin's lymphomas: the role of the 14;18 translocation. J Clin Oncol. 1988 May;6(5):919-25. doi: 10.1200/JCO.1988.6.5.919.
- Background: PubMed 24362818Okosun J, Bodor C, Wang J, Araf S, Yang CY, Pan C, Boller S, Cittaro D, Bozek M, Iqbal S, Matthews J, Wrench D, Marzec J, Tawana K, Popov N, O'Riain C, O'Shea D, Carlotti E, Davies A, Lawrie CH, Matolcsy A, Calaminici M, Norton A, Byers RJ, Mein C, Stupka E, Lister TA, Lenz G, Montoto S, Gribben JG, Fan Y, Grosschedl R, Chelala C, Fitzgibbon J. Integrated genomic analysis identifies recurrent mutations and evolution patterns driving the initiation and progression of follicular lymphoma. Nat Genet. 2014 Feb;46(2):176-181. doi: 10.1038/ng.2856. Epub 2013 Dec 22.
- Background: PubMed 23777769Tan D, Horning SJ, Hoppe RT, Levy R, Rosenberg SA, Sigal BM, Warnke RA, Natkunam Y, Han SS, Yuen A, Plevritis SK, Advani RH. Improvements in observed and relative survival in follicular grade 1-2 lymphoma during 4 decades: the Stanford University experience. Blood. 2013 Aug 8;122(6):981-7. doi: 10.1182/blood-2013-03-491514. Epub 2013 Jun 18.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Lymphoma and Relapsed/Refractory Follicular Lymphoma, run by European Hematology Association - Lymphoma Group at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, Netherlands, Croatia, Italy, Portugal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanne Tonino, MD (020 56 64447 ext. 0031, hemat.trial@amc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Progression of disease within 24 months from start of second line treatment (second POD24) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04587388, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.