Trial Title:
French Observational Study of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in Real-World Settings
NCT ID:
NCT05590702
Condition:
CLL/SLL
Conditions: Official terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
First line therapy
Description:
Patient with CLL or SLL requiring a therapeutic strategy according to iwCLL criteria or
investigator evaluation will be identified in MCM (multidisciplinary collegial meeting).
Patients will be treated and managed according to the decision of their physicians and
the related MDM. No treatment plan is recommended in the setting of this
non-interventional study.
Summary:
Chronic lymphocytic leukemia (CLL) is the most frequent form of leukemia in the Western
World. The disease is characterized by the accumulation and proliferation of mature,
monoclonal, CD5+ B-cells with specific immunophenotype in the peripheral blood (above
5x109/L), bone marrow and secondary lymphoid organs. Small lymphocytic leukemia (SLL) is
characterized by similar tumor cells but without increased lymphocyte count. The
management of these patients have considerably changed over the last decade. Indeed,
beyond chemo-immunotherapy, multiple targeted therapies have been approved on the basis
of phase 2 and randomized phase 3 clinical trials and have subsequently been used in
daily practice. The management of patients with SLL is similar to that of those with CLL.
In addition to therapeutic advances, the advent of new sequencing technologies has also
identified CLL genetic features that are now being incorporated in patient routine
evaluation.
We here propose to set a large-scale prospective and non-interventional study including
patients with symptomatic CLL/SLL with the aim to evaluate the real-world clinical
management of these patients and to identify the impact of treatments and therapeutic
trajectories on long-term outcome.
Detailed description:
Chronic lymphocytic leukemia (CLL) is the most frequent form of leukemia in the Western
World. The disease is characterized by the accumulation and proliferation of mature,
monoclonal, CD5+ B-cells with specific immunophenotype in the peripheral blood (above
5x109/L), bone marrow and secondary lymphoid organs. Small lymphocytic leukemia (SLL) is
characterized by similar tumor cells but without increased lymphocyte count. In Europe,
CLL has been identified as the second most frequent hematological malignancies after
multiple myeloma (Eurocare 5 study) and its standardized incidence in the world has been
estimated to be 4/100000 person-years for men and 2.1/100000 person-years for women. In
France, 4674 new cases have been observed in 2018 (FRANCIM). A proportion of patients can
initially be monitored only while others with symptomatic disease at diagnosis or during
follow-up require therapies. The management of these patients have considerably changed
over the last decade. Indeed, beyond chemo-immunotherapy, multiple targeted therapies
have been approved on the basis of phase 2 and randomized phase 3 clinical trials and
have subsequently been used in daily practice. The management of patients with SLL is
similar to that of those with CLL. In addition to therapeutic advances, the advent of new
sequencing technologies has also identified CLL genetic features that are now being
incorporated in patient routine evaluation.
Conventional chemo-immunotherapy (CIT) has been the long-standing option for CLL patient
without TP53 disruption and different regimens have emerged depending on patient
comorbidities (fludarabine-cyclophosphamide-rituximab, FCR; bendamustin-rituximab, BR;
GA101-chloraminophene, G-CLB). These regimens fail to be effective in patients with TP53
disruption and alternative strategies are proposed for them.
The CLL therapeutic panel is now enriched by oral kinase inhibitors targeting the B-cell
receptor signaling. The Bruton's tyrosine kinase inhibitors (BTKi) have been shown to
provide prolonged response, even in cases where CIT usually failed, such as patients
harboring TP53 disruption. In relapsed/refractory patients, median PFS with the BTKi
ibrutinib is 44 months. In the frontline setting, ibrutinib has recently been shown to
result in superior PFS and less infectious complications than standard CIT regimens.
The advent of the BCL2 (B-cell lymphoma 2) inhibitor venetoclax has recently added
another option for the treatment of CLL patients. BCL2 is an antiapoptotic molecule
governing mitochondrial apoptosis and is strongly expressed in CLL cells. Inhibiting BCL2
with venetoclax as monotherapy led to 79% response rate in the relapse/refractory
setting. Combining venetoclax to rituximab demonstrated better PFS than
bendamustine-rituximab in relapsed/refractory patients.
However, these treatment approaches also come with new challenges that are difficult
to-address in phase 3 clinical trials and that deserve larger scale studies and longer
follow-up. The emergence of drug resistance, the changes of safety profiles to deal with
in routine practice and the observance of these orally administered drugs are emerging as
new concerns. How these compounds change the incidence of typical CLL complication such
as Richter transformation, immune cytopenias and infections remains to be determined. A
growing body of concerns is also raising regarding the unlimited administration of some
of this the compounds (costs, resistance, tolerance). Finally, the optimal order of use
of these drugs is unknown.
The advent of the BCL2 (B-cell lymphoma 2) inhibitor venetoclax has recently added
another option for the treatment of CLL patients 11,12. BCL2 is an antiapoptotic molecule
governing mitochondrial apoptosis and is strongly expressed in CLL cells. Inhibiting BCL2
with venetoclax as monotherapy led to 79% response rate in the relapse/refractory
setting. Combining venetoclax to rituximab demonstrated better PFS than
bendamustine-rituximab in relapsed/refractory patients12.
However, these treatment approaches also come with new challenges that are difficult
to-address in phase 3 clinical trials and that deserve larger scale studies and longer
follow-up. The emergence of drug resistance, the changes of safety profiles to deal with
in routine practice and the observance of these orally administered drugs are emerging as
new concerns. How these compounds change the incidence of typical CLL complication such
as Richter transformation, immune cytopenias and infections remains to be determined. A
growing body of concerns is also raising regarding the unlimited administration of some
of this the compounds (costs, resistance, tolerance). Finally, the optimal order of use
of these drugs is unknown.
Primary objective : Setting a prospective cohort of real-world CLL/SLL patients with
symptomatic disease in order to evaluate medical practices and their change and
representativity over time.
Secondary objectives : Overall survival and long-term toxicity, Response and PFS at each
line of therapy, Impact of therapeutic trajectories on patient outcome, Representativity
of the studied population
Criteria for eligibility:
Study pop:
Patient with CLL or SLL requiring a therapeutic strategy according to iwCLL criteria or
investigator evaluation will be identified in MCM (multidisciplinary collegial meeting).
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age ≥ 18-year old
- CLL or SLL requiring a therapeutic strategy according to iwCLL criteria or
investigator evaluation
- Patient requiring therapy for immune events (autoimmune Thrombocytopenia and
autoimmune hemolytic anemia) are eligible
- Patients who have been informed verbally and in writing about this study, and who do
not object to their data being electronically processed or subjected to data quality
control
- All consecutive patients for whom a discussion in the setting of local or regional
multidisciplinary collegial meeting (in french : réunion de concertation
pluridisciplinaire / RCP) has retained the need for starting a therapeutic strategy
(curative or palliative)
- Patients with untreated or previously treated CLL/SLL are both eligible
- Patients enrolled in a clinical trial can be included in this non-interventional
cohort study
- Patients requiring therapy for CLL/SLL-associated immune events only are also
eligible
Exclusion Criteria:
- Patients with no need of therapy
- Patients with asymptomatic Binet A CLL
- Patient with Richter's syndrome at inclusion
- Patient requiring immunoglobulin substitution (with no need of a more specific
therapy)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AMIENS - CH Amiens Picardie Site Sud
Address:
City:
Amiens
Zip:
80054
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pierre MOREL
Phone:
+33 3 22 45 59 14
Email:
morel.pierre@chu-amiens.fr
Facility:
Name:
Angers Chu
Address:
City:
Angers
Zip:
49933
Country:
France
Status:
Recruiting
Contact:
Last name:
Aline CLAVERT, MD
Phone:
+33 2 41 35 45 24
Email:
aline.clavert@chu-angers.fr
Facility:
Name:
ANNECY - CH Annecy Genevois
Address:
City:
Annecy
Zip:
74374
Country:
France
Status:
Recruiting
Contact:
Last name:
Stéphanie TARDY, MD
Phone:
+334 50 63 66 08
Email:
stardy@ch-annecygenevois.fr
Facility:
Name:
ARGENTEUIL - Centre hospitalier Victor Dupouy
Address:
City:
Argenteuil
Country:
France
Status:
Recruiting
Contact:
Last name:
Driss CHAOUI
Facility:
Name:
AVIGNON - Centre Hospitalier
Address:
City:
Avignon
Zip:
84000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Safia CHEBREK, Dr
Phone:
+33 4 32 75 93 00
Email:
chebrek.safia@ch-avignon.fr
Facility:
Name:
BESANCON - Hôpital Jean Minjoz
Address:
City:
Besançon
Zip:
25000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Annie BRION, MD
Phone:
+33381668232
Email:
abrion@chu-besancon.fr
Facility:
Name:
BLOIS CH
Address:
City:
Blois
Zip:
41000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Abderrazak EL YAMANI, MD
Phone:
+33254556405
Email:
elyamaa@ch-blois.fr
Facility:
Name:
APHP - Hôpital Avicenne
Address:
City:
Bobigny
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Vincent LEVY, Pr
Facility:
Name:
APHP - Hôpital Jean Verdier
Address:
City:
Bondy
Zip:
93140
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Laurent GILARDIN
Email:
laurent.gilardin@aphp.fr
Facility:
Name:
BOURGOUIN-JALLIEU - CH Pierre Oudot
Address:
City:
Bourgoin-Jallieu
Zip:
38300
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Florence LACHENAL
Email:
flachenal@ghnd.fr
Facility:
Name:
BREST - Hôpital Morvan - Hématologie Clinique
Address:
City:
Brest
Zip:
29609
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Cristina BAGACEAN, Dr
Phone:
+33 2 98 22 35 04
Email:
cristina.bagacean@chu-brest.fr
Facility:
Name:
BEZIERS - Centre Hospitalier - Hématologie
Address:
City:
Béziers
Zip:
34500
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Alain SAAD, Dr
Phone:
+33 4 67 35 70 63
Email:
alain.saad@ch-beziers.fr
Facility:
Name:
CAEN - IHBN - Hématologie Clinique
Address:
City:
Caen
Zip:
14033
Country:
France
Status:
Recruiting
Contact:
Last name:
Baptiste MOISDON DELAPIERRE, Dr
Email:
delapierre-ba@chu-caen.fr
Facility:
Name:
CERGY PONTOISE - CH René Dubos
Address:
City:
Cergy-Pontoise
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
ioana Vaida, Dr
Email:
ioana.vaida@ght-novo.fr
Facility:
Name:
CHAMBERY - CH Métropole Savoie
Address:
City:
Chambéry
Zip:
73000
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre FAURIE
Email:
pierre.faurie@ch-metropole-savoie.fr
Facility:
Name:
Clermont-Ferrand - Chu Estaing
Address:
City:
Clermont-Ferrand
Zip:
63000
Country:
France
Status:
Recruiting
Contact:
Last name:
Romain Guieze, MD
Phone:
+33473750766
Email:
rguieze@chu-clermontferrand.fr
Facility:
Name:
Corbeil-Essonnes - Chsf
Address:
City:
Corbeil-Essonnes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Laurence SIMON, Dr
Email:
laurence.simon@chsf.fr
Facility:
Name:
Dijon Chu
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Philippine ROBERT
Email:
philippine.robert@chu-dijon.fr
Facility:
Name:
GRENOBLE GHM - Institut Daniel Hollard
Address:
City:
Grenoble
Zip:
38028
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Caroline ALGRIN, Dr
Phone:
33(0)4 76 28 52 32
Email:
c.algrin@ghm-grenoble.fr
Facility:
Name:
Grenoble - CHUGA - Hématologie Clinique
Address:
City:
Grenoble
Zip:
38043
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sylvain CARRAS, Dr
Email:
Scarras@chu-grenoble.fr
Facility:
Name:
La Roche Sur Yon - Chd Vendee
Address:
City:
La Roche-sur-Yon
Zip:
85925
Country:
France
Status:
Recruiting
Contact:
Last name:
Komivi Agbetsivi, MD
Phone:
+33251446173
Email:
komivi.agbetsivi@ght85.fr
Facility:
Name:
Le Mans CH
Address:
City:
Le Mans
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Kamel Laribi, Dr
Email:
klaribi@ch-lemans.fr
Facility:
Name:
LENS - GHT Artois
Address:
City:
Lens
Zip:
62300
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Daniela ROBU
Email:
drobu@ch-lens.fr
Facility:
Name:
LIBOURNE - Hôpital Robert Boulin
Address:
City:
Libourne
Zip:
33505
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Diane LARA
Email:
diane.lara@ch-libourne.fr
Facility:
Name:
LILLE GHICL - Hôpital Saint Vincent de Paul
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Bénédicte HIVERT, Dr
Phone:
33 (0)3 20 87 45 32
Email:
hivert.benedicte@ghicl.net
Facility:
Name:
LILLE CHU - Hôpital Claude Huriez
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Recruiting
Contact:
Last name:
Morgane NUDEL
Email:
morgane.nudel@chru-lille.fr
Facility:
Name:
LIMOGES - CHU Dupuytren 1
Address:
City:
Limoges
Zip:
87042
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Nataliya DMYTRUC
Email:
nataliya.dmytruk@chu-limoges.fr
Facility:
Name:
LYON-Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Anne-Sophie MICHALLET, MD
Email:
anne-sophie.michallet@lyon.unicancer.fr
Facility:
Name:
METZ-THIONVILLE CHR- Hôpital de Mercy
Address:
City:
Metz
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Philippe CARRASSOU, Dr
Email:
p.carassou@chr-metz-thionville.fr
Facility:
Name:
MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique
Address:
City:
Montpellier
Zip:
34295
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Charles HERBAUX, Dr
Email:
c-herbaux@chu-montpellier.fr
Facility:
Name:
MORLAIX - CH des pays de Morlaix
Address:
City:
Morlaix
Zip:
29672
Country:
France
Status:
Recruiting
Contact:
Last name:
Vincent REBIERE
Email:
VRebiere@ch-morlaix.fr
Facility:
Name:
Mulhouse - Ghrmsa
Address:
City:
Mulhouse
Zip:
68100
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Bernard DRENOU, Dr
Phone:
03 89 64 77 85
Email:
drenoub@ghrmsa.fr
Facility:
Name:
NANTES - Hôpital Hôtel Dieu - Hématologie Clinique
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Recruiting
Contact:
Last name:
Anne LOK, Dr
Email:
anne.lok@chu-nantes.fr
Facility:
Name:
NIMES - CHU Caremeau
Address:
City:
Nîmes
Zip:
30029
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Agathe RASCALOU-WAULTIER, Dr
Email:
agathe.waultier.rascalou@chu-nimes.fr
Facility:
Name:
ORLEANS - CHR - Hématologie
Address:
City:
Orléans
Zip:
44100
Country:
France
Status:
Recruiting
Contact:
Last name:
Omar BENBRAHIM, Dr
Email:
omar.benbrahim@chr-orleans.fr
Facility:
Name:
APHP - HOPITAL COCHIN - Hématologie
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Lise WILLEMS, Dr
Phone:
+33(0)1 58 41 26 70
Email:
lise.willems@aphp.fr
Facility:
Name:
APHP - Hôpital Pitié Salpêtrière - Hématologie
Address:
City:
Paris
Zip:
75651
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Damien ROOS-WEIL, Pr
Phone:
01 42 16 28 24
Email:
damien.roos-weil@psl.aphp.fr
Facility:
Name:
PERPIGNAN - CH St Jean - Hématologie Clinique
Address:
City:
Perpignan
Zip:
66000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Laurence SANHES, Dr
Email:
laurence.sanhes@ch-perpignan.fr
Facility:
Name:
Bordeaux Pessac
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Recruiting
Contact:
Last name:
Marie-Sarah DILHUYDY, MD
Phone:
+33557656511
Email:
marie-sarah.dilhuydy@chu-bordeaux.fr
Facility:
Name:
LYON HCL - CH Lyon Sud
Address:
City:
Pierre-Bénite
Zip:
69036
Country:
France
Status:
Recruiting
Contact:
Last name:
Emmanuelle FERRAND, MD
Email:
emmanuelle.ferrant2@chu-lyon.fr
Facility:
Name:
Perigueux - Ch
Address:
City:
Périgueux
Zip:
24000
Country:
France
Status:
Recruiting
Contact:
Last name:
Claire CALMETTES
Email:
claire.calmettes@ch-perigueux.fr
Facility:
Name:
QUIMPER - CH de Cornouaille
Address:
City:
Quimper
Zip:
29000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Kristell MAHE
Email:
kristell.mahe@ch-cornouaille.fr
Facility:
Name:
Reims Chu
Address:
City:
Reims
Zip:
51092
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Anne QUINQUENEL, Dr
Phone:
33 (0)3 26 78 36 44
Email:
aquiquennel@chu-reims.fr
Facility:
Name:
RENNES - CHU Pontchaillou - Hématologie Clinique
Address:
City:
Rennes
Zip:
35033
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sophie DE GUIBERT, Pr
Phone:
02 99 28 42 91
Email:
sophie.de.guibert@chu-rennes.fr
Facility:
Name:
RENNES - Hôpital Pontchaillou - Hématologie
Address:
City:
Rennes
Zip:
35033
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marc BERNARD, Dr
Phone:
+33(0)2 99 28 99 86
Email:
marc.bernard@chu-rennes.fr
Facility:
Name:
ROUEN - Centre Henri Becquerel - Service Hématologie Clinique
Address:
City:
Rouen
Zip:
76038
Country:
France
Status:
Recruiting
Contact:
Last name:
Stéphane LEPRETRE, Pr
Phone:
+33 2 32 08 29 46
Email:
stephane.lepretre@chb.unicancer.fr
Facility:
Name:
SAINT-BRIEUC - Hôpila Yves Le Foll
Address:
City:
Saint-Brieuc
Zip:
22027
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Thomas NIVET
Email:
thomas.nivet@armorsante.bzh
Facility:
Name:
La Reunion - Gh Site Sud
Address:
City:
Saint-pierre
Country:
France
Status:
Recruiting
Contact:
Last name:
Hugo LEGENDRE
Email:
hugo.legendre@chu-reunion.fr
Facility:
Name:
ST ETIENNE - CHU et Institut De Cancérologie Lucien Neuwirth
Address:
City:
Saint-Priest-en-Jarez
Country:
France
Status:
Recruiting
Contact:
Last name:
FRessia HONEYMAN
Email:
fressia.honeyman@icloire.fr
Facility:
Name:
Strasbourg - Icans
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Luc FORNECKER, MD
Email:
lm.fornecker@icans.eu
Facility:
Name:
Toulouse - IUCT Oncopole - Service d'Hématologie
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Loïc YSEBAERT, Pr
Email:
ysebaert.loic@iuct-oncopole.fr
Facility:
Name:
TOURS - Hôpital Bretonneau
Address:
City:
Tours
Zip:
37000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Caroline DARTIGEAS, MD
Email:
c.dartigeas@chu-tours.fr
Facility:
Name:
Troyes Ch
Address:
City:
Troyes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Nadia ALI AMMAR, Dr
Email:
nadia.aliammar@hcs-sante.fr
Facility:
Name:
NANCY - CHU Brabois
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54500
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pierre FEUGIER, Pr
Phone:
33 (0)3 83 15 32 82
Email:
p.feugier@chru-nancy.fr
Facility:
Name:
Vannes - Chba
Address:
City:
Vannes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Antoine BONNET, Dr
Facility:
Name:
VERSAILLES - Hôpital André Mignot
Address:
City:
Versailles
Country:
France
Status:
Recruiting
Contact:
Last name:
Fatiha MERABET, Dr
Facility:
Name:
Villejuif Igr
Address:
City:
Villejuif
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
David GHEZ, Dr
Email:
david.ghez@igr.fr
Start date:
November 11, 2022
Completion date:
December 1, 2032
Lead sponsor:
Agency:
French Innovative Leukemia Organisation
Agency class:
Other
Collaborator:
Agency:
AbbVie
Agency class:
Industry
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
BeiGene
Agency class:
Industry
Collaborator:
Agency:
Janssen-Cilag Ltd.
Agency class:
Industry
Source:
French Innovative Leukemia Organisation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05590702
