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AzTrials

Diffuse Large B Cell Lymphoma CD20 PositivePhase 3GAINEDNCT01659099

GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma

A Phase 3 study testing GA101, Rituximab and Doxorubicin in people with Diffuse Large B Cell Lymphoma CD20 Positive, run by The Lymphoma Academic Research Organisation at 122 sites in 2 countries.

Terminated

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

Official record
Search all trials

Trial summary

This study is designed to investigate: the interest of a new monoclonal antibody (GA101)versus rituximab the interest of PET to identify early responders Patients will receive either rituximab (standard treatment), either GA101 (study treatment), according to the randomization arm. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
GA101, Rituximab and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
671 participants
Where
122 sitesin 2 countries
Study dates
Sep 2012to 31 Dec 2017
Phase
Phase 3
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification)
  • Baseline PET scan available with at least one hypermetabolic lesion
  • Aged ≥ 18 years and ≤ 60 years
  • Eligible for autologous stem cell transplant
  • Patient not previously treated
  • Age adjusted International Prognostic Index (aa-IPI) equal to 1, 2 or 3
Show all 12Show fewer
  • Life expectancy ≥ 3 months
  • Negative HIV, HBV (anti-HBc negativity) and HCV serologies before inclusion
  • Having signed a written informed consent
  • Having ability and willingness to comply with study protocol procedures
  • Men must agree to use a barrier method of contraception during the treatment period and until 3 months after the last dose of GA101 or rituximab, or ACVBP14 or CHOP14 chemotherapy, whichever is longer
  • Women of childbearing potential must agree to use an adequate method of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception during the treatment period and until 12 months after the last dose of GA101, Rituximab, ACVBP14, or CHOP14 chemotherapy, whichever is longer

Who cannot join

  • Any other histological type of lymphoma
  • Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included
  • Central nervous system or meningeal involvement by lymphoma
  • Contra-indication to any drug contained in the chemotherapy regimens
  • Poor cardiac function (LVEF < 50%) on echocardiogram or MUGA scan
  • Poor renal function (creatinine level > 150*mol/l or clearance < 30ml/min), poor hepatic function (total bilirubin level > 30µmol/l, transaminases > 2.5 X maximum normal level) unless these abnormalities are related to the lymphoma
Show all 13Show fewer
  • Poor bone marrow reserve as defined by neutrophils < 1.5 G/L or platelets < 100 G/L, unless related to bone marrow infiltration
  • Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
  • Any serious active disease (according to the investigator's decision)
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy
  • Pregnant or lactating women
  • Adult patient under tutelage
  • Prior history of Progressive Multifocal Leukoencephalopathy (PML)

Trial locations and contacts

122 sites in 2 countries.

122 sites in 2 countries

France98 sites

  • CH d'Abbeville

    Abbeville, 80142

  • CHU d'Amiens - Hôpital Sud

    Amiens, 80054

  • CHU d'Angers

    Angers, 49033

  • CH Victor Dupouy

    Argenteuil, 95100

  • CH d'Arras

    Arras, 62022

  • CH d'Avignon

    Avignon, 84902

  • Hôpital de Bayonne - CHU de la Côte Basque

    Bayonne, 64109

  • CH de Beauvais

    Beauvais, 60000

  • CHU de Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • CH de Blois

    Blois, 41016

  • APHP - Hôpital Avicenne

    Bobigny, 93000

  • Institut Bergonié

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077

  • CH Dr Duchenne

    Boulogne-sur-Mer, 62321

  • CH Fleyriat

    Bourg-en-Bresse, 01012

  • CHU de Brest - Hôpital de Morvan

    Brest, 29609

  • CH Brive la Gaillarde

    Brive-la-Gaillarde, 19100

  • CHU de Caen

    Caen, 14033

  • Centre François Baclesse

    Caen, 14076

  • CH de Cannes

    Cannes, 06400

  • Clinique Du Parc

    Castelnau-le-Lez, 34170

  • CHU de Châlon sur Saône

    Châlon Sur Saône, 71100

  • CH de Chambéry

    Chambéry, 73011

  • APHP - Hôpital Antoine Béclère

    Clamart, 92140

  • Hôpital d'Instruction des Armées Percy

    Clamart, 92141

  • CHU d'Estaing

    Clermont-Ferrand, 63003

  • Pôle Santé Publique

    Clermont-Ferrand, 63050

  • CH de Compiègne

    Compiègne, 60200

  • CH Sud Francilien

    Corbeil-Essonnes, 91100

  • APHP - Hôpital Henri Mondor

    Créteil, 94010

  • CHU de Dijon

    Dijon, 21000

  • CH de Dunkerque

    Dunkirk, 59385

  • Institut Daniel Hollard

    Grenoble, 38000

  • CHU de Grenoble

    Grenoble, 38043

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • CH La Rochelle

    La Rochelle, 17019

  • APHP - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275

  • CH du Mans

    Le Mans, 72000

  • Clinique Victor Hugo

    Le Mans, 72000

  • CH de Lens

    Lens, 62307

  • CH Saint Vincent de Paul

    Lille, 59000

  • CHRU Lille - Hôpital Claude Huriez

    Lille, 59037

  • CHU Dupruytren - Limoges

    Limoges, 87042

  • CH Bretagne Sud

    Lorient, 56100

  • Centre Léon Bérard

    Lyon, 69008

  • CH Mantes La Jolie

    Mantes-la-Jolie, 78201

  • Hôpital de la Conception

    Marseille, 13005

  • Institut Paoli Calmettes

    Marseille, 13009

  • CH de Meaux

    Meaux, 77100

  • CH Marc Jacquet

    Melun, 77011

  • Hôpital Notre Dame Bon Secours

    Metz, 57038

  • CHI de Meulan

    Meulan-en-Yvelines, 78250

  • CHU de Montpellier - Saint Eloi

    Montpellier, 34295

  • Centre Val d'Aurélie - Paul Lamarque

    Montpellier, 34298

  • Centre Auréen de Cancérologie

    Mougins, 06250

  • CH de Mulhouse - Hôpital Emile Muller

    Mulhouse, 68070

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093

  • Centre Catherine de Sienne

    Nantes, 44200

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHU de Nice

    Nice, 06202

  • CHU de Nîmes

    Nîmes, 30029

  • Clinique Valdegour

    Nîmes, 30900

  • CHR d'Orléans

    Orléans, 45067

  • Institut Curie

    Paris, 75005

  • APHP - Hôpital de la Pitié Salpetrière

    Paris, 75013

  • Hôpital Cochin

    Paris, 75014

  • APHP - Hôpital Necker

    Paris, 75015

  • APHP - Hôpital Saint Louis

    Paris, 75475

  • APHP - Hôpital Saint Antoine

    Paris, 75571

  • CH Saint Jean

    Perpignan, 66000

  • CHU de Haut Lévèque

    Pessac, 33604

  • Hospices Civils de Lyon - CHU Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Poitiers

    Poitiers, 86000

  • CH René Dubos

    Pontoise, 95300

  • CH d'Annecy

    Pringy, 74370

  • CHU Robert Debré

    Reims, 51100

  • Institut du Cancer de Courlancy

    Reims, 51100

  • CHU de Rennes

    Rennes, 35033

  • CH de Roubaix

    Roubaix, 59100

  • Centre Henri Becquerel

    Rouen, 76000

  • Clinique Mathilde

    Rouen, 76000

  • CH Yves Le Foll - St Brieuc

    Saint-Brieuc, 22000

  • Centre René Huguenin

    Saint-Cloud, 92210

  • CHI de Poissy St Germain

    Saint-Germain-en-Laye, 78105

  • Institut de Cancérologie

    Saint-Priest-en-Jarez, 42270

  • CH de Saint Quentin

    Saint-Quentin, 21000

  • CHU de Saint Malo

    St-Malo, 35400

  • Strasbourg Oncologie Libérale

    Strasbourg, 67000

  • CHU de Strasbourg

    Strasbourg, 67098

  • Hopital Saint Husse

    Toulon, 83100

  • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

    Toulouse, 31059

  • CHU de Tours

    Tours, 37000

  • CHU de Valence

    Valence, 26953

  • CH de Valenciennes

    Valenciennes, 59322

  • CHU de Brabois

    Vandœuvre-lès-Nancy, 54511

  • CH Bretagne Atlantique

    Vannes, 56017

  • CH de Versailles

    Versailles, 78750

  • Institut Gustave Roussy

    Villejuif, 84085

Other trials in France

Belgium24 sites

  • ZNA Stuivenberg

    Antwerp, 2060

  • Hôpital Saint Joseph

    Arlon, 6700

  • RHMS Baudour

    Baudour, 7331

  • AZ St Jan Brugge Oostende AV

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • CHU Brugmann

    Brussels, 1020

  • Hôpital Erasme

    Brussels, 1070

  • Clinique universitaire Saint LUC

    Brussels, 1200

  • CHU de Charleroi

    Charleroi, 6000

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • Universitair Ziekenhuis Gent

    Ghent, 900

  • Ch Jolimont

    Haine-Saint-Paul, 7100

  • AZ GROENINGE - Oncology Centre - Campus Maria's Voorzienigheid

    Kortrijk, 8500

  • CHR de la Citadelle

    Liège, 4000

  • CHU de Liège - Clinique Saint Joseph

    Liège, 4000

  • CHU de Liège -Domaine Sart Tilman

    Liège, 4000

  • CHU Ambroise Paré

    Mons, 7000

  • Clinique Saint Joseph -Hôpital de Warquignies

    Mons, 7000

  • Clinique Sainte Elisabeth

    Namur, 5000

  • Clinique Saint Pierre

    Ottignies, 1340

  • Heilig Hart Ziekenhuis

    Roeselare, 8800

  • Centre Hospitalier de Wallonie Picarde - CHwapi

    Tournai, 7500

  • CH de la Tourelle-Peltzer

    Verviers, 4800

  • Université Catholique de Louvain Mont Godinne

    Yvoir, 5530

Other trials in Belgium

About this study

Official title: Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognostic Factors of the Age-adjusted IPI

This study is designed to investigate:

  • the interest of a new monoclonal antibody (GA101)versus rituximab
  • the interest of PET to identify early responders

Patients will receive either rituximab (standard treatment), either GA101 (study treatment), according to the randomization arm.

The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to site's choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and after 4 chemotherapy cycles, to identify early patients responders, for who consolidation with ASCT is not required.

Keywords
DLBCL, aa-IPI > or equal to 1, Diagnosis, 18 to 60 years, Lymphoma
Medical subject headings
Disease, Lymphoma

What participants receive

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

  • GA101Drug

    Also called obinutuzumab, Gazivaro

    in GA-ACBVP or in GA-CHOP 1000 mg on D1 and D8 (D8 in cycle 1 and 2)

  • RituximabDrug

    Also called Mabthera

    in R-ACBVP or in R-CHOP 375 mg/m² on D1

  • DoxorubicinDrug

    in ACBVP : 75 mg/m² on D1 in CHOP : 50 mg/m² on D1

  • CyclophosphamideDrug

    in ACBVP : 1200 mg/m² on D1 in CHOP : 750 mg/m² on D1

  • PrednisoneDrug

    in ACBVP : 60 mg/m² from D1 to D5 in CHOP : 40 mg/m² from D1 to D5

  • BleomycinDrug

    in ACBVP 10 mg from D1 to D5

  • VindesinDrug

    in ACBVP 2 mg/m² from D1 to D5

  • VincristineDrug

    in CHOP 1,4 mg/m² on D1

Study groups in NCT01659099
Study groupRoleWhat they receive
GA101ExperimentalGA101 - Chemotherapy (ACVBP or CHOP)
Receives: Drug: GA101; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Prednisone; Drug: Bleomycin; Drug: Vindesin; Drug: Vincristine
RituximabActive comparatorRituximab - Chemotherapy (ACVBP or CHOP)
Receives: Drug: Rituximab; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Prednisone; Drug: Bleomycin; Drug: Vindesin; Drug: Vincristine

What is being measured

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

  1. 2-year Event Free Survival

    EFS is defined as PET positivity according to ΔSUVmax criteria after 2 or 4 induction cycles as defined by RAC (based on central PET review), progression or relapse according to Cheson 2007, modification of planned treatment out of progression or death of any cause.

    Measured: Up to 2 years

Secondary outcomes (9)

  1. • Overall Response rate and Best overall response after 4 cycles and end of treatment according to Cheson 2007 criteria

    Response will be assessed after 4 cycles and again at the end of treatment, based on RAC assessment for PET 4 and investigator assessment for EoT PET. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 2007). Overall (CR//PR) response rates and Best Response Rate will be presented. Patient without response assessment (due to whatever reason) will be considered as non-responder.

    Measured: Up to 3.5years

  2. • Overall Response Rate and Best overall response after 4 cycles and end of treatment according to Cheson 1999 criteria

    Response will be assessed after 4 cycles and at the end of treatment, based on investigator assessment. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 1999). Overall (CR/CRu/PR) response rates and Best Overall Response Rate will be presented. Patient without response assessment (due to whatever reason) will be considered as non-responder.

    Measured: Up to 3.5 years

  3. • Duration of response (DoR)

    Duration of response is defined as the period from the time of attainment a CR or PR to the date of progression, relapse or death from any cause. Duration or response would be assessed as survival in the whole population, in the two inductive arms (R-Chemo14 vs GA101-Chemo14) For patients achieving a response but who have not progressed or relapsed or died at the time of analysis, DOR will be censored on the date of last disease assessment

    Measured: Up to 6.5 years

  4. • Progression-Free Survival (PFS)

    Progression-Free Survival is defined as the period from the date of randomization to the date of first documented disease progression, relapse, or death from any cause. For patients who have not progressed, relapsed, or died at the time of analysis, PFS will be censored on the date of last disease assessment. If no tumor assessments were performed after the baseline visit, PFS will be censored at the time of randomization

    Measured: Up to 6.5 years

  5. • Overall survival (OS)

    Overall survival is defined as the period from the date of randomization to the date of death from any cause. Alive patients at the time of the analysis will be censored at their last contact date

    Measured: Up to 6.5 years

  6. • Blood samples and on tumor tissue biopsy

    Analysis on blood samples and tumor tissue biopsy will be driven, in order to explore prognosis factors of the patients and their tumors that influence treatment response based on PET assessment and prognosis

    Measured: Up to 6.5 years

  7. • Focus on subpopulation

    Duration of response, PFS and OS will be performed according to treatment arms (R-Chemo14 vs GA101-Chemo14) on different analysis populations. The subpopulations are based on the outcome during the induction phase and a statistical bias could be introduced as subpopulations have not been defined at baseline.

    • Population with a Δ SUVmaxPET0-2≤66% (slow and intermediate responders),
    • Population with a Δ SUVmaxPET0-2>66% (fast responders),
    • Patients submitted to autologous stem cell transplant (PFS and OS only)

    Measured: Up to 6.5 years

  8. Number of stem cell collected after GA101 treatment

    Number of stem cell collected after GA101 administration Number of required collects to achieve 3Mcells/kg.

    Measured: Up to 3.5 years

  9. • Early metabolic response according to PET after 2 and 4 cycles

    Based on results of central PET review

    Measured: Up to 3.5 years

Timeline

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

  1. First posted7 Aug 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionAug 2016
  4. Study completion31 Dec 2017

Why it stopped: experimental treatment not Superior to standard - no need to continue the follow-up

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
671 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01659099
Sponsor's protocol ID
GAINED
Acronym
GAINED
Status last verified
Mar 2018
First submitted
4 Jul 2012
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Camus V, Molina T, Desmots F, Blanc-Durand P, Kanoun S, Moslemi A, Ruminy P, Le Gouill S, Ghesquieres H, Oberic L, Morschhauser F, Tilly H, Ribrag V, Houot R, Thieblemont C, Maisonneuve H, Claves F, Bouabdallah K, Haioun C, Damaj GL, Fornecker LM, Noel R, Feugier P, Sibon D, Cartron G, Bonnet C, Bernard W, Kraeber-Bodere F, Bodet-Milin C, Jais JP, Briere J, Rossi C, Elsensohn MH, Chartier L, Itti E, Jardin F, Fest T. Interim PET after 4 cycles predicts outcome in histomolecularly confirmed primary mediastinal B-cell lymphoma. Blood Adv. 2025 May 13;9(9):2232-2246. doi: 10.1182/bloodadvances.2024015577.

    PubMed 40030008

  • Itti E, Blanc-Durand P, Berriolo-Riedinger A, Kanoun S, Kraeber-Bodere F, Meignan M, Gat E, Gouill SL, Casasnovas RO, Bodet-Milin C. Validation of the DeltaSUVmax for Interim PET Interpretation in Diffuse Large B-Cell Lymphoma on the Basis of the GAINED Clinical Trial. J Nucl Med. 2023 Nov;64(11):1706-1711. doi: 10.2967/jnumed.123.265871. Epub 2023 Sep 21.

    PubMed 37734837

  • Jullien M, Tessoulin B, Ghesquieres H, Oberic L, Morschhauser F, Tilly H, Ribrag V, Lamy T, Thieblemont C, Villemagne B, Gressin R, Bouabdallah K, Haioun C, Damaj G, Fornecker LM, Schiano De Colella JM, Feugier P, Hermine O, Cartron G, Bonnet C, Andre M, Bailly C, Casasnovas RO, Le Gouill S. Deep-Learning Assessed Muscular Hypodensity Independently Predicts Mortality in DLBCL Patients Younger Than 60 Years. Cancers (Basel). 2021 Sep 7;13(18):4503. doi: 10.3390/cancers13184503.

    PubMed 34572728

  • Le Gouill S, Ghesquieres H, Oberic L, Morschhauser F, Tilly H, Ribrag V, Lamy T, Thieblemont C, Maisonneuve H, Gressin R, Bouhabdallah K, Haioun C, Damaj G, Fornecker L, Bouhabdallah R, Feugier P, Sibon D, Cartron G, Bonnet C, Andre M, Chartier L, Ruminy P, Kraeber-Bodere F, Bodet-Milin C, Berriolo-Riedinger A, Briere J, Jais JP, Molina TJ, Itti E, Casasnovas RO. Obinutuzumab vs rituximab for advanced DLBCL: a PET-guided and randomized phase 3 study by LYSA. Blood. 2021 Apr 29;137(17):2307-2320. doi: 10.1182/blood.2020008750.

    PubMed 33211799

  • Blanc-Durand P, Jegou S, Kanoun S, Berriolo-Riedinger A, Bodet-Milin C, Kraeber-Bodere F, Carlier T, Le Gouill S, Casasnovas RO, Meignan M, Itti E. Fully automatic segmentation of diffuse large B cell lymphoma lesions on 3D FDG-PET/CT for total metabolic tumour volume prediction using a convolutional neural network. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1362-1370. doi: 10.1007/s00259-020-05080-7. Epub 2020 Oct 24.

    PubMed 33097974

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GA101, Rituximab and Doxorubicin in people with Diffuse Large B Cell Lymphoma CD20 Positive, run by The Lymphoma Academic Research Organisation at 122 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 12 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 122 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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: experimental treatment not Superior to standard - no need to continue the follow-up). 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?

2-year Event Free Survival (time frame: Up to 2 years). 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 NCT01659099, which also lists 5 linked publications.

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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