Study Stopped
Treament with rituximab during maintenance phase was stoped, according to DSMC recommendations, since 3 cases of deaths occured.
BRIEF Bendamustine and Rituximab In Elderly Follicular
BRIEF
BRIEF: Bendamustine and Rituximab In Elderly Follicular: A Multicentric Phase II Study Evaluating the Benefit of a Short Induction Treatment by Bendamustine and Rituximab Followed by Maintenance Therapy With Rituximab In Elderly (≥ 60 Years Old) Patients With Untreated Follicular Lymphoma Patients, With an Intermediate or High FLIPI Score
1 other identifier
interventional
62
2 countries
117
Brief Summary
The objective of this study is to evaluate the complete response rate after a short induction treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60 years old) patients with untreated Follicular lymphoma, with an intermediate or high FLIPI score and without high tumor burden. This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30 Maintenance schedule: 12 infusions of rituximab, each 8 weeks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2011
Longer than P75 for phase_2
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 21, 2011
CompletedFirst Posted
Study publicly available on registry
March 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 7, 2018
March 1, 2018
1.7 years
February 21, 2011
March 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine
12 weeks
Secondary Outcomes (9)
Complete response rate according to Cheson criteria 1999 after 24 months of maintenance therapy with Rituximab
26 months
Partial and objective response rates at the end of induction phase
12 weeks
Duration of response
From the time of attainment of CR or PR to the date of first documented disease progression, relapse or death from any cause
Progression free survival
From the date of randomization to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause.
Overall survival
From the date of randomization to the date of death from any cause
- +4 more secondary outcomes
Study Arms (1)
Rituximab + bendamustine
EXPERIMENTALInterventions
Induction phase: rituximab and bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, Rituximab on Day 22, bendamustine on Day 29, Bendamustine on Day 30
Eligibility Criteria
You may qualify if:
- Histologically confirmed follicular lymphoma CD20+, all grades except the grade 3b with a lymph node biopsy performed within 6 months before study entry and with material available for central review
- A minimal initial immunology is required, including : CD20, bcl-2, CD10 and CD5
- Age must be ≥ 60 years
- Patients not previously treated
- Patients with an intermediate or high risk FLIPI score requiring 2 or more of the following adverse prognostic factors:
- Age \>60 ans
- Ann Arbor Stage (III-IV vs. I-II)
- Hemoglobin level ( \< 12g/dL vs. ≥ 12 g/dL)
- Number of nodal areas (\< 5 vs. ≥ 5) (Note: LDH should not be considered as an adverse prognostic factor in this study since it is considered as high tumor burden in the GELF criteria)
- Low burden disease at study entry according to the GELF criteria
- Patients with at least one measurable site of disease: patients with only blood or marrow or splenic infiltration are excluded
- Performance status ≤ 2 on the ECOG scale
- Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) including:
- Hemoglobin ≥ 8.0 g/dL (5.0 mmol/L)
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- +5 more criteria
You may not qualify if:
- Other histological types of lymphoma than follicular lymphoma
- Grade 3b follicular lymphoma
- Patients previously on watch and wait since more than 6 months from diagnosis
- Patients previously treated for lymphoma, except splenectomy
- Patients with low FLIPI score (0 or 1 adverse prognostic factors not considering elevated LDH)
- Bulky disease at study entry according to the GELF criteria
- Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis)
- Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer or previous cancer in CR without any treatment in the last 5 years
- Poor Performance status \> 2 on the ECOG scale
- Known contra-indication to study product
- Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
- Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (117)
ZNA Stuivenberg
Antwerp, B-2060, Belgium
Clinique Sud du Luxembourg
Arlon, B-6700, Belgium
RHMS
Baudour, Belgium
A. Z. Sint-Jan
Bruges, B-8000, Belgium
CHU Brugmann
Brussels, B-1020, Belgium
Université Libre de Bruxelles - Hôpital Erasme
Brussels, B-1070, Belgium
Université Catholique de Louvain Saint Luc
Brussels, B-1200, Belgium
CH Notre Dame
Charleroi, B-6000, Belgium
CHU Charleroi-Vésale
Charleroi, B-6000, Belgium
Centre de Santé des Fagnes
Chimay, B-6460, Belgium
Clinique Notre Dame de Grace
Gosselies, B-6041, Belgium
Hôpital Jolimont
Haine-Saint-Paul, B-7100, Belgium
CH Hutois
Huy, B-4500, Belgium
AZ Groeninge - Campus Maria's Voorzienigheid
Kortrljk, B-8500, Belgium
CHU Tivoli
La Louvière, B-7100, Belgium
CHR de la Citadelle
Liège, B-4000, Belgium
CHU de Liège
Liège, B-4000, Belgium
CHU Ambroise Paré
Mons, B-7000, Belgium
Clinique Saint Joseph
Mons, B-7000, Belgium
Hôpital Sainte Elisabeth
Namur, B-5000, Belgium
Heilig Hart Ziekenhuis
Roeselare, B-8800, Belgium
Centre Hospitalier de Wallonie Picarde - CHwapi
Tournai, B-7500, Belgium
CH de la Tourelle-Peltzer
Verviers, B-4800, Belgium
UCL Mt Godinne
Yvoir, B-5530, Belgium
CH du Pays d'Aix
Aix-en-Provence, 13616, France
CHU Amiens - Hôpital Sud
Amiens, 80054, France
CHU d'Angers
Angers, 49033, France
CH Antibes
Antibes, 06606, France
CH Victor Dupouy
Argenteuil, 95107, France
CH d'Avignon - Hôpital Henri Dufaut
Avignon, 84000, France
Hôpital de Bayonne
Bayonne, 64100, France
Centre Hospitalier de Beauvais
Beauvais, 60021, France
CH Jean Minjoz
Besançon, 25030, France
CH Béziers
Béziers, 34500, France
Centre Hospitalier de Blois
Blois, 41016, France
Institut Bergonié
Bordeaux, 33076, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
CH Dr Duchenne
Boulogne-sur-Mer, 62200, France
CH de Bourg en Bresse
Bourg-en-Bresse, 01012, France
CHU Morvan
Brest, 26609, France
Centre Hospitalier de Brive
Brive-la-Gaillarde, 19100, France
CHU Clémenceau
Caen, 14033, France
Centre Francois Baclesse
Caen, 14076, France
CH Cannes
Cannes, 06401, France
CH Chambéry
Chambéry, 73011, France
CH de Chartres
Chartres, 28018, France
Hôpital de Châlon
Châlon Sur Saône, 71100, France
Hôpital Antoine Béclère
Clamart, 92140, France
Hôpital d'Instruction des Armées Percy
Clamart, 92141, France
CHU Estaing
Clermont-Ferrand, 63003, France
Pôle Santé Publique
Clermont-Ferrand, 63050, France
CH de Compiègne
Compiègne, 60321, France
Hôpital Sud Francilien
Corbeil Essonne, 91108, France
Hôpital Henri Mondor
Créteil, 94010, France
CHU le Bocage
Dijon, 21034, France
CH de Dunkerque
Dunkirk, 59385, France
CH Fréjus St Raphaël
Fréjus, 83608, France
CHU Grenoble
Grenoble, 38043, France
Centre Hospitalier de Guéret
Guéret, 23000, France
CHD Vendée
La Roche-sur-Yon, 85925, France
Centre Hospitalier de Laval
Laval, 53015, France
Hôpital André Mignot
Le Chesnay, 78157, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275, France
CH Le Mans
Le Mans, 72000, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72015, France
CHRU de Lille - Hôpital Claude Huriez
Lille, 59037, France
CHU LIMOGES - Hôpital Universitaire Dupuytren
Limoges, 87042, France
CH de Bretagne Sud
Lorient, 56100, France
Clinique de la Sauvegarde
Lyon, 69009, France
Centre Léon Bérard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13273, France
CH les Chanaux
Mâcon, 71018, France
CH de Meaux
Meaux, 77100, France
Ch Marc Jacquet
Melun, 77011, France
Hôpital Notre Dame de Bon Secours
Metz, 57038, France
CH Saint-Eloi
Montpellier, 34295, France
CRCL Val d'Aurelle
Montpellier, 34298, France
Centre Azuréen de Cancérologie
Mougins, 06250, France
CHU de Mulhouse - Hôpital Emile Muller
Mulhouse, 68070, France
Centre Catherine de Sienne
Nantes, 44000, France
CHU Hôtel Dieu
Nantes, 44093, France
Hôpital Américain de Paris
Neuilly, 92202, France
Centre Antoine Lacassagne
Nice, 06189, France
CHU de Nice
Nice, 06202, France
CHU Caremeau
Nîmes, 30029, France
Clinique Valdegour
Nîmes, 30907, France
CHR de la Source
Orléans, 45067, France
Hôpital Saint Antoine
Paris, 75012, France
Hôpital de la Pitié Salpétrière
Paris, 75013, France
Hôpital Necker
Paris, 75015, France
Hôpital Hôtel Dieu
Paris, 75181, France
Institut Curie
Paris, 75181, France
Hôpital St Louis
Paris, 75475, France
Hôpital Saint Antoine
Paris, 75571, France
CH Saint Jean
Perpignan, 66046, France
Hôpital Haut Levêque
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, 86021, France
CH René Dubos
Pontoise, 95300, France
Centre Hospitalier de la Région d'Annecy
Pringy, 74374, France
Hôpital Robert Debré
Reims, 51092, France
Clinique de Courlancy
Reims, 51100, France
Hôpital Pontchaillou
Rennes, 35033, France
Centre Henri Becquerel
Rouen, 76038, France
Clinique Mathilde
Rouen, 76100, France
CHU Saint-Etienne
Saint Priest En Jarest, 42271, France
Centre René Huguenin
Saint-Cloud, 92211, France
CHG St Germain
Saint-Germain-en-Laye, 78105, France
CH de Saint Quentin
Saint-Quentin, 02321, France
CHU de Saint Malo
St-Malo, 35400, France
Hôpital Font Pré
Toulon, 83056, France
CHU Bretonneau
Tours, 37044, France
Hôpital de Troyes
Troyes, 10000, France
CH de Valence
Valence, 26953, France
CHU Nancy Brabois
Vandœuvre-lès-Nancy, 54511, France
Centre Hospitalier Bretagne Atlantique
Vannes, 56017, France
Institut Gustave Roussy
Villejuif, 94805, France
Related Publications (1)
Gyan E, Sonet A, Brice P, Anglaret B, Laribi K, Fruchart C, Tilly H, Araujo C, Soubeyran P, Gonzalez H, Morineau N, Nicolas-Virelizier E, Ghesquieres H, Salles B, Bouabdallah R, Orfeuvre H, Fahri J, Couturier O, Xerri L, Feugier P; Lymphoma Study Association (LYSA). Bendamustine and rituximab in elderly patients with low-tumour burden follicular lymphoma. Results of the LYSA phase II BRIEF study. Br J Haematol. 2018 Oct;183(1):76-86. doi: 10.1111/bjh.15513. Epub 2018 Aug 16.
PMID: 30117149DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre FEUGIER, MD
CHU Brabois, 54511 Vandoeuvre les Nancy
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2011
First Posted
March 14, 2011
Study Start
February 1, 2011
Primary Completion
October 1, 2012
Study Completion
December 1, 2017
Last Updated
March 7, 2018
Record last verified: 2018-03