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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hôpital 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
        • Hôpital André 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
        • Hôpital Necker
      • Paris, France, 75013
        • Hôpital de la Pitié Salpêtrière
      • 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
        • Hôpital Haut Levêque
      • Pierre Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86021
        • CHU De Poitiers - Hopital De La Miletrie
      • Pontoise, France, 95300
        • CH René Dubos
      • Pringy, France, 74374
        • Centre hospitalier de la région d'Annecy
      • Reims, France, 51092
        • Hopital Robert Debre
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Lymphoma Academic Research Organisation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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