BRIEF Bendamustine and Rituximab In Elderly Follicular

This study has been terminated.
(Treament with rituximab during maintenance phase was stoped, according to DSMC recommendations, since 3 cases of deaths occured.)
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier:
NCT01313611
First received: February 21, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Follicular Lymphoma
Drug: Rituximab + bendamustine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by The Lymphoma Academic Research Organisation:

Primary Outcome Measures:
  • Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response rate according to Cheson criteria 1999 after 24 months of maintenance therapy with Rituximab [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Partial and objective response rates at the end of induction phase [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: From the time of attainment of CR or PR to the date of first documented disease progression, relapse or death from any cause ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From the date of randomization to the date of death from any cause ] [ Designated as safety issue: No ]
  • Time before retreatment [ Time Frame: From the end of primary treatment until the institution of the next therapy ] [ Designated as safety issue: No ]
  • Immediate toxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Long term toxicity [ Time Frame: Until death of the patients ] [ Designated as safety issue: Yes ]
  • Evaluation of QoL [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: February 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab+bendamustine Drug: Rituximab + bendamustine
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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Age >60 ans
    2. Ann Arbor Stage (III-IV vs. I-II)
    3. Hemoglobin level ( < 12g/dL vs. ≥ 12 g/dL)
    4. 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
  • Platelet count ≥ 100 x 109/L
  • Adequate renal function: calculated creatinine clearance > 50 ml/min (according to MDRD method) unless these abnormalities are related to lymphoma
  • Adequate hepatic function: Total bilirubin < 2.0 mg/dl (34 µmol/L), AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal unless these abnormalities are related to lymphoma
  • Adequate cardiac function: LEVF ≥ 50% calculated by echocardiography or scintigraphy
  • Having previously signed a written informed consent

Exclusion Criteria:

  • 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
  • Positive HIV, HBV (anti-HBc positivity) and HCV serologies before inclusion
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313611

  Hide Study Locations
Locations
Belgium
ZNA Stuivenberg
Antwerpen, Belgium, B-2060
Clinique Sud du Luxembourg
Arlon, Belgium, B-6700
RHMS
Baudour, Belgium
A. Z. Sint-Jan
Bruges, Belgium, B-8000
Université Libre de Bruxelles - Hôpital Erasme
Bruxelles, Belgium, B-1070
Université Catholique de Louvain Saint Luc
Bruxelles, Belgium, B-1200
CHU Brugmann
Bruxelles, Belgium, B-1020
CH Notre Dame
Charleroi, Belgium, B-6000
CHU Charleroi-Vésale
Charleroi, Belgium, B-6000
Centre de Santé des Fagnes
Chimay, Belgium, B-6460
Clinique Notre Dame de Grace
Gosselies, Belgium, B-6041
Hôpital Jolimont
Haine Saint Paul, Belgium, B-7100
CH Hutois
Huy, Belgium, B-4500
AZ Groeninge - Campus Maria's Voorzienigheid
Kortrljk, Belgium, B-8500
CHU Tivoli
La Louviere, Belgium, B-7100
CHU de Liège
Liège, Belgium, B-4000
CHR de la Citadelle
Liège, Belgium, B-4000
Clinique Saint Joseph
Mons, Belgium, B-7000
CHU Ambroise Paré
Mons, Belgium, B-7000
Hôpital Sainte Elisabeth
Namur, Belgium, B-5000
Heilig Hart Ziekenhuis
Roeselare, Belgium, B-8800
Centre Hospitalier de Wallonie Picarde - CHwapi
Tournai, Belgium, B-7500
CH de la Tourelle-Peltzer
Verviers, Belgium, B-4800
UCL Mt Godinne
Yvoir, Belgium, B-5530
France
CH du Pays d'Aix
Aix En Provence, France, 13616
CHU Amiens - Hôpital Sud
Amiens, France, 80054
CHU d'Angers
Angers, France, 49033
CH Antibes
Antibes, France, 06606
CH Victor Dupouy
Argenteuil, France, 95107
CH d'Avignon - Hôpital Henri Dufaut
Avignon, France, 84000
Hôpital de Bayonne
Bayonne, France, 64100
Centre Hospitalier de Beauvais
Beauvais, France, 60021
CH Jean Minjoz
Besancon, France, 25030
Centre Hospitalier de Blois
Blois, France, 41016
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Institut Bergonié
Bordeaux, France, 33076
CH Dr Duchenne
Boulogne sur mer, France, 62200
CH de Bourg en Bresse
Bourg en Bresse, France, 01012
CHU Morvan
Brest, France, 26609
Centre Hospitalier de Brive
Brive La Gaillarde, France, 19100
CH Béziers
Béziers, France, 34500
CHU Clémenceau
Caen, France, 14033
Centre Francois Baclesse
Caen, France, 14076
CH Cannes
Cannes, France, 06401
CH Chambéry
Chambéry, France, 73011
CH de Chartres
Chartres, France, 28018
Hôpital de Châlon
Châlon sur Saône, France, 71100
Hôpital Antoine Béclère
Clamart, France, 92140
Hôpital d'Instruction des Armées Percy
Clamart, France, 92141
Pôle Santé Publique
Clermont-Ferrand, France, 63050
CHU Estaing
Clermont-Ferrand, France, 63003
CH de Compiègne
Compiègne, France, 60321
Hôpital Sud Francilien
Corbeil Essonne, France, 91108
Hôpital Henri Mondor
Créteil, France, 94010
CHU le Bocage
Dijon, France, 21034
CH de Dunkerque
Dunkerque, France, 59385
CH Fréjus St Raphaël
Fréjus, France, 83608
CHU Grenoble
Grenoble, France, 38043
Centre Hospitalier de Guéret
Gueret, France, 23000
Hôpital Bicêtre
Kremlin Bicêtre, France, 94275
CHD Vendée
La Roche sur Yon, France, 85925
Centre Hospitalier de Laval
Laval, France, 53015
Hôpital André Mignot
Le Chesnay, France, 78157
CH Le Mans
Le Mans, France, 72000
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, France, 72015
CHRU de Lille - Hôpital Claude Huriez
Lille, France, 59037
CHU LIMOGES - Hôpital Universitaire Dupuytren
Limoges, France, 87042
CH de Bretagne Sud
Lorient, France, 56100
Clinique de la Sauvegarde
Lyon, France, 69009
Centre Léon Bérard
Lyon, France, 69373
CH les Chanaux
Macon, France, 71018
Institut Paoli Calmettes
Marseille, France, 13273
CH de Meaux
Meaux, France, 77100
Ch Marc Jacquet
Melun, France, 77011
Hôpital Notre Dame de Bon Secours
Metz, France, 57038
CH Saint-Eloi
Montpellier, France, 34295
CRCL Val d'Aurelle
Montpellier, France, 34298
Centre Azuréen de Cancérologie
Mougins, France, 06250
CHU de Mulhouse - Hôpital Emile Muller
Mulhouse, France, 68070
CHU Hôtel Dieu
Nantes, France, 44093
Centre Catherine de Sienne
Nantes, France, 44000
Hôpital Américain de Paris
Neuilly, France, 92202
Centre Antoine Lacassagne
Nice, France, 06189
CHU de Nice
Nice, France, 06202
CHU Caremeau
Nimes, France, 30029
Clinique Valdegour
Nimes, France, 30907
CHR de la Source
Orléans, France, 45067
Institut Curie
Paris, France, 75181
Hôpital Hôtel Dieu
Paris, France, 75181
Hôpital St Louis
Paris, France, 75475
Hôpital Saint Antoine
Paris, France, 75012
Hôpital Necker
Paris, France, 75015
Hôpital Saint Antoine
Paris, France, 75571
Hôpital de la Pitié Salpétrière
Paris, France, 75013
CH Saint Jean
Perpignan, France, 66046
Hôpital Haut Levêque
Pessac, France, 33604
Centre Hospitalier Lyon Sud
Pierre Bénite, France, 69495
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, France, 86021
CH René Dubos
Pontoise, France, 95300
Centre Hospitalier de la Région d'Annecy
Pringy, France, 74374
Clinique de Courlancy
Reims, France, 51100
Hôpital Robert Debré
Reims, France, 51092
Hôpital Pontchaillou
Rennes, France, 35033
Centre Henri Becquerel
Rouen, France, 76038
Clinique Mathilde
Rouen, France, 76100
Centre René Huguenin
Saint Cloud, France, 92211
CHU de Saint Malo
Saint Malo, France, 35400
CHU Saint-Etienne
Saint Priest en Jarest, France, 42271
CH de Saint Quentin
Saint-quentin, France, 02321
CHG St Germain
St Germain en Laye, France, 78105
Hôpital Font Pré
Toulon, France, 83056
CHU Bretonneau
Tours, France, 37044
Hôpital de Troyes
Troyes, France, 10000
CH de Valence
Valence, France, 26953
CHU Nancy Brabois
Vandoeuvre les Nancy, France, 54511
Centre Hospitalier Bretagne Atlantique
Vannes, France, 56017
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Investigators
Principal Investigator: Pierre FEUGIER, MD CHU Brabois, 54511 Vandoeuvre les Nancy
  More Information

No publications provided

Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT01313611     History of Changes
Other Study ID Numbers: BRIEF
Study First Received: February 21, 2011
Last Updated: May 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bendamustine
Nitrogen Mustard Compounds
Rituximab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 20, 2014