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Follicular LymphomaPhase 2BRIEFNCT01313611

BRIEF Bendamustine and Rituximab In Elderly Follicular

A Phase 2 study testing Rituximab + bendamustine in people with Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 117 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Rituximab + bendamustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
117 sitesin 2 countries
Study dates
Feb 2011to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

117 sites in 2 countries.

117 sites in 2 countries

France93 sites

  • CH du Pays d'Aix

    Aix-en-Provence, 13616

  • CHU Amiens - Hôpital Sud

    Amiens, 80054

  • CHU d'Angers

    Angers, 49033

  • CH Antibes

    Antibes, 06606

  • CH Victor Dupouy

    Argenteuil, 95107

  • CH d'Avignon - Hôpital Henri Dufaut

    Avignon, 84000

  • Hôpital de Bayonne

    Bayonne, 64100

  • Centre Hospitalier de Beauvais

    Beauvais, 60021

  • CH Jean Minjoz

    Besançon, 25030

  • CH Béziers

    Béziers, 34500

  • Centre Hospitalier de Blois

    Blois, 41016

  • Institut Bergonié

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • CH Dr Duchenne

    Boulogne-sur-Mer, 62200

  • CH de Bourg en Bresse

    Bourg-en-Bresse, 01012

  • CHU Morvan

    Brest, 26609

  • Centre Hospitalier de Brive

    Brive-la-Gaillarde, 19100

  • CHU Clémenceau

    Caen, 14033

  • Centre Francois Baclesse

    Caen, 14076

  • CH Cannes

    Cannes, 06401

  • Hôpital de Châlon

    Châlon Sur Saône, 71100

  • CH Chambéry

    Chambéry, 73011

  • CH de Chartres

    Chartres, 28018

  • Hôpital Antoine Béclère

    Clamart, 92140

  • Hôpital d'Instruction des Armées Percy

    Clamart, 92141

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Pôle Santé Publique

    Clermont-Ferrand, 63050

  • CH de Compiègne

    Compiègne, 60321

  • Hôpital Sud Francilien

    Corbeil Essonne, 91108

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU le Bocage

    Dijon, 21034

  • CH de Dunkerque

    Dunkirk, 59385

  • CH Fréjus St Raphaël

    Fréjus, 83608

  • CHU Grenoble

    Grenoble, 38043

  • Centre Hospitalier de Guéret

    Guéret, 23000

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • Centre Hospitalier de Laval

    Laval, 53015

  • Hôpital André Mignot

    Le Chesnay, 78157

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275

  • CH Le Mans

    Le Mans, 72000

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, 72015

  • CHRU de Lille - Hôpital Claude Huriez

    Lille, 59037

  • CHU LIMOGES - Hôpital Universitaire Dupuytren

    Limoges, 87042

  • CH de Bretagne Sud

    Lorient, 56100

  • Clinique de la Sauvegarde

    Lyon, 69009

  • Centre Léon Bérard

    Lyon, 69373

  • CH les Chanaux

    Mâcon, 71018

  • Institut Paoli Calmettes

    Marseille, 13273

  • CH de Meaux

    Meaux, 77100

  • Ch Marc Jacquet

    Melun, 77011

  • Hôpital Notre Dame de Bon Secours

    Metz, 57038

  • CH Saint-Eloi

    Montpellier, 34295

  • CRCL Val d'Aurelle

    Montpellier, 34298

  • Centre Azuréen de Cancérologie

    Mougins, 06250

  • CHU de Mulhouse - Hôpital Emile Muller

    Mulhouse, 68070

  • Centre Catherine de Sienne

    Nantes, 44000

  • CHU Hôtel Dieu

    Nantes, 44093

  • Hôpital Américain de Paris

    Neuilly, 92202

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHU de Nice

    Nice, 06202

  • CHU Caremeau

    Nîmes, 30029

  • Clinique Valdegour

    Nîmes, 30907

  • CHR de la Source

    Orléans, 45067

  • Hôpital Saint Antoine

    Paris, 75012

  • Hôpital de la Pitié Salpétrière

    Paris, 75013

  • Hôpital Necker

    Paris, 75015

  • Hôpital Hôtel Dieu

    Paris, 75181

  • Institut Curie

    Paris, 75181

  • Hôpital St Louis

    Paris, 75475

  • Hôpital Saint Antoine

    Paris, 75571

  • CH Saint Jean

    Perpignan, 66046

  • Hôpital Haut Levêque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Poitiers - Hôpital de la Milétrie

    Poitiers, 86021

  • CH René Dubos

    Pontoise, 95300

  • Centre Hospitalier de la Région d'Annecy

    Pringy, 74374

  • Hôpital Robert Debré

    Reims, 51092

  • Clinique de Courlancy

    Reims, 51100

  • Hôpital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Clinique Mathilde

    Rouen, 76100

  • CHU Saint-Etienne

    Saint Priest En Jarest, 42271

  • Centre René Huguenin

    Saint-Cloud, 92211

  • CHG St Germain

    Saint-Germain-en-Laye, 78105

  • CH de Saint Quentin

    Saint-Quentin, 02321

  • CHU de Saint Malo

    St-Malo, 35400

  • Hôpital Font Pré

    Toulon, 83056

  • CHU Bretonneau

    Tours, 37044

  • Hôpital de Troyes

    Troyes, 10000

  • CH de Valence

    Valence, 26953

  • CHU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511

  • Centre Hospitalier Bretagne Atlantique

    Vannes, 56017

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Belgium24 sites

  • ZNA Stuivenberg

    Antwerp, B-2060

  • Clinique Sud du Luxembourg

    Arlon, B-6700

  • RHMS

    Baudour

  • A. Z. Sint-Jan

    Bruges, B-8000

  • CHU Brugmann

    Brussels, B-1020

  • Université Libre de Bruxelles - Hôpital Erasme

    Brussels, B-1070

  • Université Catholique de Louvain Saint Luc

    Brussels, B-1200

  • CH Notre Dame

    Charleroi, B-6000

  • CHU Charleroi-Vésale

    Charleroi, B-6000

  • Centre de Santé des Fagnes

    Chimay, B-6460

  • Clinique Notre Dame de Grace

    Gosselies, B-6041

  • Hôpital Jolimont

    Haine-Saint-Paul, B-7100

  • CH Hutois

    Huy, B-4500

  • AZ Groeninge - Campus Maria's Voorzienigheid

    Kortrljk, B-8500

  • CHU Tivoli

    La Louvière, B-7100

  • CHR de la Citadelle

    Liège, B-4000

  • CHU de Liège

    Liège, B-4000

  • CHU Ambroise Paré

    Mons, B-7000

  • Clinique Saint Joseph

    Mons, B-7000

  • Hôpital Sainte Elisabeth

    Namur, B-5000

  • Heilig Hart Ziekenhuis

    Roeselare, B-8800

  • Centre Hospitalier de Wallonie Picarde - CHwapi

    Tournai, B-7500

  • CH de la Tourelle-Peltzer

    Verviers, B-4800

  • UCL Mt Godinne

    Yvoir, B-5530

Other trials in Belgium

About this study

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

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

Being tested
Rituximab + bendamustine
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rituximab + bendamustineDrug

    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

Study groups in NCT01313611
Study groupRoleWhat they receive
Rituximab + bendamustineExperimentalNot described
Receives: Drug: Rituximab + bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine

    Measured: 12 weeks

Secondary outcomes (9)

  1. Complete response rate according to Cheson criteria 1999 after 24 months of maintenance therapy with Rituximab

    Measured: 26 months

  2. Partial and objective response rates at the end of induction phase

    Measured: 12 weeks

  3. Duration of response

    Measured: From the time of attainment of CR or PR to the date of first documented disease progression, relapse or death from any cause

  4. Progression free survival

    Measured: 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.

  5. Overall survival

    Measured: From the date of randomization to the date of death from any cause

  6. Time before retreatment

    Measured: From the end of primary treatment until the institution of the next therapy

  7. Immediate toxicity

    Measured: 12 weeks

  8. Long term toxicity

    Measured: Until death of the patients

  9. Evaluation of QoL

    Measured: 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionOct 2012
  4. Study completionDec 2017

Why it stopped: Treament with rituximab during maintenance phase was stoped, according to DSMC recommendations, since 3 cases of deaths occured.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01313611
Sponsor's protocol ID
BRIEF
Acronym
BRIEF
Status last verified
Mar 2018
First submitted
21 Feb 2011
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30117149

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab + bendamustine in people with Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 117 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Treament with rituximab during maintenance phase was stoped, according to DSMC recommendations, since 3 cases of deaths occured.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate according to Cheson criteria 1999 after a short induction treatment by rituximab and bendamustine (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01313611, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.

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