BRIEF Bendamustine and Rituximab In Elderly Follicular (BRIEF)

March 6, 2018 updated by: The Lymphoma Academic Research Organisation

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete response rate according to Cheson criteria 1999 after 24 months of maintenance therapy with Rituximab
Time Frame: 26 months
26 months
Partial and objective response rates at the end of induction phase
Time Frame: 12 weeks
12 weeks
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
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
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.
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
Time Frame: From the date of randomization to the date of death from any cause
From the date of randomization to the date of death from any cause
Time before retreatment
Time Frame: From the end of primary treatment until the institution of the next therapy
From the end of primary treatment until the institution of the next therapy
Immediate toxicity
Time Frame: 12 weeks
12 weeks
Long term toxicity
Time Frame: Until death of the patients
Until death of the patients
Evaluation of QoL
Time Frame: 7 years
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Lymphoma Academic Research Organisation

Investigators

  • Principal Investigator: Pierre FEUGIER, MD, CHU Brabois, 54511 Vandoeuvre les Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

March 10, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRIEF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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