Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5

NCT06284122 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: MorningLyte
• Study Type: interventional
• Target: 790
• Locations: 7 countries
• Sites: 116

Brief Summary

This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  time from randomization to the date of first documented disease progression/relapse or death from any cause, by Lugano 2014

  130 PFS events assessed by an Independent Review Committee (IRC) (4.6 years)

• Progression Free Survival (PFS)

  time from randomization to the date of first documented disease progression/relapse or death from any cause, by Lugano 2014

  173 PFS events assessed by IRC (5.8 y)

Secondary Outcomes (35)

• Overall Response (OR)

  6 months

• Complete Metabolic Rate (CMR)

  6 months

• Overall Response (OR)

  12 months

• Complete Metabolic Rate (CMR)

  12 months

• Overall Response (OR) and Complete Response (CR) rate at EOT

  4.6 years

Study Arms (5)

Mosun-Len

EXPERIMENTAL

Mosunetuzumab + lenalidomide

Drug: Mosunetuzumab; Drug: Lenalidomide

R-CHOP

ACTIVE COMPARATOR

Rituximab-CHOP

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristin; Drug: Prednisone

G-CHOP

ACTIVE COMPARATOR

Obinutuzumab-CHOP

Drug: Obinutuzumab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristin; Drug: Prednisone

R-Benda

ACTIVE COMPARATOR

Rituximab-Bendamustin

Drug: Rituximab; Drug: Bendamustin

G-Benda

ACTIVE COMPARATOR

Obinutuzumab-Bendamustin

Drug: Obinutuzumab; Drug: Bendamustin

Interventions

Mosunetuzumab DRUG

5 mg (step-up dosing) Day 1 of C1 45 mg Day 8 and Day 15 of C1, 45 mg Day 1 from C2 to C12, 45 mg Day 1 from C13 to C21

Mosun-Len

Lenalidomide DRUG

Lenalidomide starting dose is based on patient's creatinine clearance. Day 1 to Day 21 from C2 to C12

Mosun-Len

Rituximab DRUG

when associated to CHOP IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2 to C6 Day 1 from C7 to C20

R-CHOP

Obinutuzumab DRUG

when associated to CHOP 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from C9 to C18

G-CHOP

Cyclophosphamide DRUG

750 mg/m2 Day 1 from C1 to C6

G-CHOP; R-CHOP

Doxorubicin DRUG

50 mg/m2 Day 1 from C1 to C6

G-CHOP; R-CHOP

Vincristin DRUG

1.4 mg/m2 (cap cf. below)$ Day 1 from C1 to C6

G-CHOP; R-CHOP

Prednisone DRUG

100 mg/day Day 1 to Day 5 from C1 to C6

G-CHOP; R-CHOP

Bendamustin DRUG

90 mg/m2 Day 1 and Day 2 from C1 to C6

G-Benda; R-Benda

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patient with histologically proven previously untreated CD20+ follicular lymphoma grade 1, 2, or 3a (including patient watched during up to 10 years after initial diagnosis) as assessed by the investigators according to the WHO 2016 classification12, or classical follicular lymphoma according to the WHO 2022 classification13. Diagnostic tissue must be available for central pathology review, exploratory endpoints and secondary data use.
• FLIPI 2-5.
• All Ann Arbor stages (including stage I if FLIPI ≥ 2).
• Must need treatment as evidenced by at least one of the following criteria:
• Bulky disease defined as one of the following: 4.1.1. a nodal or extranodal mass/lesion \> 70 mm in its largest diameter or, 4.1.2. involvement of at least 3 different nodal or extranodal sites (each with a diameter greater than \> 30 mm) 4.2. Presence of at least one of the following B symptoms within the prior 6 months: 4.2.1. fever (\> 38°C) of unclear etiology 4.2.2. night sweats 4.2.3. weight loss greater than 10% 4.3. Symptomatic splenomegaly 4.4. Symptomatic lesion: 4.4.1. painful lesion and/or 4.4.2. any compressive syndrome (for example, but not restricted to- ureteral, orbital, gastrointestinal) 4.5. Any one of the following cytopenias due to lymphoma: 4.5.1. hemoglobin \< 10g/dL (6.25 mmol/L) 4.5.2. platelets \<100 x 109/L, or 4.5.3. absolute neutrophil count (ANC) \< 1.5 x 109/L 4.6. Pleural or peritoneal serous effusion (irrespective of cell content) 4.7. Abnormal biological prognostic parameters: (item not applicable for Germany) 4.7.1. β2microglobulin \> ULN or 4.7.2. LDH \> ULN
• At least one bi-dimensionally measurable nodal lesion, defined as \> 15 mm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as \> 10 mm in its longest dimension (and FDG-avid lesion).
• Participant who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures.
• Must be ≥ 18 years old at the time of signing the informed consent form (ICF).
• ECOG performance status 0 to 2.
• Estimated minimum life expectancy of 3 months.
• Adequate hematological function within 28 days prior to randomization, including:
• Absolute neutrophil count (ANC) ≥ 1 x 109/L 10.2. Platelet count ≥ 75 x 109/L, or ≥ 30 x 109/L if bone marrow infiltration or splenomegaly 10.3. Hemoglobin ≥ 8.0 g/dL (5 mmol/L) unless related to bone marrow infiltration or splenomegaly. Transfusion is allowed before starting treatment (no required window)
• Normal laboratory values:
• Measured or estimated creatinine clearance ≥ 40mL/min calculated by institutional standard method (MDRD or Cockcroft-Gault 11.2. AST or ALT ≤ 2.5 x the upper limit of normal (ULN), except in patients with documented liver or pancreatic involvement by lymphoma ≤ 5 x ULN 11.3. Serum total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for patients with Gilbert syndrome), except in patients with documented liver or pancreatic involvement by lymphoma ≤ 3 x ULN
• LVEF within normal range (i.e. \> 50% as evaluated by Transthoracic Echocardiography or \> 45% as evaluated by isotopic method (MUGA scan).

You may not qualify if:

• Grade 3b follicular lymphoma according to the WHO 2016 classification12, or follicular large B-cell lymphoma according to the WHO 2022 classification13
• Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment.
• Examples: patients with high or intermediate high SUV (\>20) in any nodal or extranodal site particularly in the bones (vertebrae etc) unless biopsy proven to be genuine FL grade 1,2, 3A ; and/or discordant (e.g. SUV doubled) with SUV of other sites including the biopsy site.; and/or LDH \> 2.5 x ULN in a context of rapidly progressive disease, etc. Please contact the Coordinating Investigator / Sponsor to discuss such cases or if there is any doubt before considering enrolment.
• Prior localized radiotherapy for the FL.
• Prior history of another lymphoma.
• Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment (within one week of finding). Participants may only be enrolled after Coordinating investigator / sponsor approval once confirmed participant is durably asymptomatic after adequate pleural/serous drainage or only if an efficient drainage device (e.g.pleurX™) is in place before randomization.
• Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure. Participants with adequate management i.e. ureteral catheter or double J stent allowing renal failure control are eligible only if urinary catheter is in place before randomization.
• Presence or history of symptomatic or threatening lymphomatous epidural/nerve root lesion, even such participants whose disease is controlled by short course of steroids are NOT eligible.
• Use of any standard or experimental anti-cancer drug therapy within 45 days of the start (Day 1) of study treatment.
• Any contraindication to any drug contained in the study treatment control arms or in the Auxiliary Medicinal Products (AxMPs)
• Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) and corticosteroids on the long run with the following exceptions: inhaled steroids for asthma, topical steroids, or replacement or stress corticosteroids during the study at any time. Participants who require lymphoma symptom control during screening may receive corticosteroid \< or = 1mg/kg/day prednisone or equivalent for a maximum of 10 days prior to first dose of study treatment
• Received a live, attenuated vaccine within 4 weeks before the first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 6 months after the final dose of study treatment.
• Major surgery (excluding surgical documentation of FL) within 28 days prior to signing informed consent.
• Seropositive for or active viral infection with hepatitis B virus (HBV):
• HBsAg positive

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation: lead
• Lymphoma Study Association: collaborator
• Swiss Cancer Institute: collaborator
• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea: collaborator

Study Sites (116)

Krankenhaus der Barmherzigen Brüder Graz - Abteilung Für Innere Medizin I

Graz, 8020, Austria

RECRUITING

Krems University Hospital - Abteilung Für Innere Medizin 2

Krems, 3500, Austria

RECRUITING

LKH HOCHSTEIERMARK - Department für Hämato-Onkologie

Leoben, 8700, Austria

RECRUITING

Kepler Universitaetsklinikum - Univ.-Klinik für Hämatologie und Internistische Onkologie

Linz, 4021, Austria

RECRUITING

Paracelsus Medical University - 3rd Medical Department

Salzburg, 5020, Austria

RECRUITING

Univ. Klinikum ST.PÖLTEN - Klinische Abteilung Für Innere Medizin 1

Sankt Pölten, 3100, Austria

RECRUITING

Medical University of Vienna - Department of Hematology and Hemostaseology

Vienna, 1090, Austria

RECRUITING

Klinikum Wels-Grieskirchen GMBH - IVth Internal Department

Wels, 4600, Austria

RECRUITING

Universitätsklinikum Wiener Neustadt - Klinische Abteilung für Innere Medizin III

Wiener Neustadt, 2700, Austria

WITHDRAWN

AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie

Bruges, 8000, Belgium

RECRUITING

INSTITUT JULES BORDET - Service Hématologie

Brussels, 1070, Belgium

RECRUITING

UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie

Brussels, 1200, Belgium

RECRUITING

GRAND HOPITAL DE CHARLEROI - Service Hématologie

Charleroi, 6000, Belgium

RECRUITING

UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie

Ghent, 9000, Belgium

RECRUITING

HELORA - Hôpital de La Louvière - Site Jolimont - Service Hématologie Clinique

La Louvière, 7100, Belgium

RECRUITING

CHU DE LIEGE - Service Hématologie

Liège, 4000, Belgium

RECRUITING

CHU UCL NAMUR - SITE GODINNE - Service Hématologie

Yvoir, 5530, Belgium

RECRUITING

CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie

Avignon, 84000, France

RECRUITING

CH DE LA COTE BASQUE - Service Hématologie

Bayonne, 64100, France

RECRUITING

CHU JEAN MINJOZ - Service Hématologie

Besançon, 25030, France

RECRUITING

INSTITUT BERGONIE - Service d'Oncologie Médicale

Bordeaux, 33076, France

RECRUITING

CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie

Cahors, 46005, France

RECRUITING

CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie

Chambéry, 73011, France

RECRUITING

CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique

Clermont-Ferrand, 63003, France

RECRUITING

HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes

Créteil, 94010, France

RECRUITING

CHU DIJON BOURGOGNE - Service Hématologie Clinique

Dijon, 21000, France

RECRUITING

CHD DE VENDEE - Service Hématologie

La Roche-sur-Yon, 85925, France

RECRUITING

CHU DE GRENOBLE - Service Hématologie

La Tronche, 38700, France

RECRUITING

HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie

Lille, 59020, France

RECRUITING

CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie

Lille, 59037, France

RECRUITING

CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire

Limoges, 87042, France

RECRUITING

INSTITUT PAOLI CALMETTES - Service Hématologie

Marseille, 13273, France

RECRUITING

CHU DE MONTPELLIER - Département d'Hématologie Clinique

Montpellier, 34090, France

RECRUITING

GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie

Mulhouse, 68100, France

RECRUITING

CHU DE NANTES - Service Hématologie

Nantes, 44093, France

RECRUITING

CENTRE HOSPITALIER DE NIORT - Médecine interne

Niort, 79021, France

RECRUITING

HOPITAL SAINT-LOUIS - Service Hématologie

Paris, 75475, France

RECRUITING

CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire

Pessac, 33604, France

RECRUITING

CHU LYON-SUD - Hématologie

Pierre-Bénite, 69495, France

RECRUITING

CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie

Poissy, 78303, France

RECRUITING

CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire

Poitiers, 86021, France

RECRUITING

CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie

Pringy, 74374, France

RECRUITING

CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie

Reims, 57092, France

RECRUITING

CHU PONTCHAILLOU - Hématologie Clinique

Rennes, 35033, France

RECRUITING

CENTRE HENRI BECQUEREL - Service Hématologie

Rouen, 76038, France

RECRUITING

INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie

Saint-Cloud, 92210, France

RECRUITING

Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie

Saint-Priest-en-Jarez, 42270, France

RECRUITING

INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique

Strasbourg, 67033, France

RECRUITING

IUCT ONCOPOLE - Service Hématologie

Toulouse, 31059, France

RECRUITING

CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire

Tours, 37044, France

RECRUITING

CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie

Valenciennes, 59322, France

RECRUITING

CHU BRABOIS - Service Hématologie

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie

Vannes, 56017, France

RECRUITING

GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique

Villejuif, 94085, France

RECRUITING

GESUNDHEITSZENTRUM ST. MARIEN GMBH - Hämatologie/Onkologie

Amberg, 92224, Germany

RECRUITING

SOZIALSTIFTUNG BAMBERG - KLINIKUM AM BRUDERWALD - Hämatologie und internistische Onkologie

Bamberg, 96049, Germany

RECRUITING

VIVANTES KLINIKUM AM URBAN - Hämatologie und Onkologie

Berlin, 10967, Germany

RECRUITING

Helios Klinikum Berlin-Buch - Klinik für Hämatologie und Stammzelltransplantation

Berlin, 13125, Germany

RECRUITING

CHARITE UNIVERSITATSMEDIZIN BERLIN - Med. Klinik m. S. Hämatologie, Onkologie, Tumorimmunologie

Berlin, 13353, Germany

RECRUITING

KLINIKUM BREMEN-MITTE - Gesundheit Nord gGmbH - Hämatologisch-Onkologische Tagesklinik

Bremen, 28205, Germany

RECRUITING

KLINIKUM CHEMNITZ GGMBH - Klinik f. Innere Medizin III

Chemnitz, 9116, Germany

RECRUITING

UNIVERSITÄTSKLINIK DÜSSELDORF-Klinik für Hämatologie, Onkologie und Klinische Immunologie

Düsseldorf, 40225, Germany

RECRUITING

UNIVERSITAETSKLINIKUM ESSEN - Klinik f. Hämatologie

Essen, 45147, Germany

WITHDRAWN

GOETHE UNIVERSITÄT FRANKFURT - Medizinische Klinik II Onkologie

Frankfurt, Germany

RECRUITING

MEDICAL CENTER - UNIVERSITY OF FREIBURG - Klinik für Innere Medizin I Hämatologie, Onkologie und Stammzelltransplantation

Freiburg im Breisgau, 79106, Germany

RECRUITING

GEORG-AUGUST-UNIV, GOETTINGEN - Klinik fur Haematologie und Medizinisched Onkologie

Göttingen, 37075, Germany

RECRUITING

UNIVERSITATSKLINIKUM HALLE (SAALE) - Klinik für Innere Medizin IV

Halle, 6097, Germany

RECRUITING

ONKOLOGIE LERCHENFELD - OncoResearch Lerchenfeld GmbH

Hamburg, 22081, Germany

WITHDRAWN

KLINIKUM REGION HANNOVER GMBH KLINIK FÜR HÄMATOLOGIE-Onkologie und immunologie

Hanover, 30459, Germany

RECRUITING

UNIVERSITÄTSKLINIKUM HEIDELBERG - Innere Medizin V

Heidelberg, 69120, Germany

RECRUITING

Universitätsklinikum des Saarlandes - Klinik für Innere Medizin I - Onkologie, Hämatol. Immun. & Rheumatololgie

Homburg, 66421, Germany

RECRUITING

UNIVERSITÄTSKLINIKUM JENA-Klinik für Innere Medizin II

Jena, 07747, Germany

RECRUITING

WESTPFALZ KLINIKUM - Klinik für Innere Medizin I

Kaiserslautern, 67655, Germany

RECRUITING

UKSH UNIVERSITAETSKLINIKUM SCHLESWIG-HOLSTEIN - Med. Klinik II - Hämatologie und Onkologie

Kiel, 24105, Germany

RECRUITING

GEMEINSCHAFTSKLINIKUM MITTELRHEIN GGMBH - Innere Medizin - Hämatologie/Onkologie

Koblenz, 56073, Germany

RECRUITING

LAKUMED KLINIKUM - Onkologisches und palliativmedizinisches Netzwerk Landshut

Landshut, 84036, Germany

RECRUITING

UNIVERSITATSKLINIKUM LUBECK - Klinik für Hämatologie und Onkologie

Lübeck, 23538, Germany

RECRUITING

KLINIKEN MARIA HILF GMBH KRANKENHAUS ST. FRANZISK - Hämatologie, Onkologie & Gastroenterologie

Mönchengladbach, 41063, Germany

RECRUITING

KLINIKUM GROSSHADERN DER LMU MUNCHEN - Hämatologie und Onkologie allgemein

München, 81377, Germany

RECRUITING

KLINIKUM RECHTS DER ISAR, III MED KLINIK DER TU - Hämatologie und Onkologie

München, 81675, Germany

RECRUITING

Gemeinschaftspraxis Fur Hamatologie Und Onkologie

Münster, 48149, Germany

RECRUITING

Universtatsklinikum Munster

Münster, 48149, Germany

RECRUITING

BRUEDERKRANKENHAUS ST. JOSEF PADERBORN - Klinik für Hämatologie und Onkologie

Paderborn, 33098, Germany

RECRUITING

MVZ FÜR HÄMATOLOGIE UND ONKOLOGIE RAVENSBURG GMBH - Hematology

Ravensburg, 86212, Germany

RECRUITING

UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III

Regensburg, 93053, Germany

RECRUITING

KLINIKUM AM STEINENBERG REUTLINGEN GMBH - Medizinische Klinik I

Reutlingen, 72764, Germany

RECRUITING

UNIVERSITÄT ROSTOCK - Hämatologie/Onkologie

Rostock, 18057, Germany

RECRUITING

AGAPLESION DIAKONIEKLINIKUM ROTENBURG - Klinik für Hämatologie, Onkologie und Nephrologie

Rotenburg (Wümme), 27356, Germany

TERMINATED

UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie

Ulm, 89081, Germany

RECRUITING

HELIOS UNIVERSITÄTSKLINIKUM WUPPERTAL - Hämatologie und Onkologie

Wuppertal, 42283, Germany

RECRUITING

UNIVERSITY WURZBURG - Hämatologie

Würzburg, 97080, Germany

RECRUITING

INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia

Lisbon, 1099, Portugal

RECRUITING

HOSPITAL UNIVERSITARIO DE ALBACETE-Servicio de Hematologia

Albacete, 02006, Spain

RECRUITING

HOSPITAL DURAN I REYNALS - ICO Oncologia

Barcelona, 08908, Spain

RECRUITING

HOSPITAL DE LA SANTA CREU I SANT PAU - Servicio de Hematología

Barcelona, 8025, Spain

RECRUITING

HOSPITAL VALL D'HEBRON - Hematology Service

Barcelona, 8035, Spain

RECRUITING

HOSPITAL CLINIC BARCELONA - Hematology department

Barcelona, 8036, Spain

RECRUITING

HOSPITAL UNIVERSITARIO DR. NEGRIN-Servicio de Hematologia

Las Palmas de Gran Canaria, 35010, Spain

RECRUITING

HOSPITAL UNIVERSITARIO ARNAU DE VILANOVA - Servicio Hematologia

Lleida, 25198, Spain

RECRUITING

HOSPITAL UNIVERSITARIO DE LA PRINCESA - Hematología

Madrid, 28006, Spain

RECRUITING

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON - Servicio de Hematología-UTMO

Madrid, 28007, Spain

RECRUITING

HOSPITAL 12 DE OCTUBRE - Servicio de Hematología y Hemoterapia

Madrid, 28041, Spain

RECRUITING

HOSPITAL PUERTA DEL HIERRO - Servicio Hematologia

Madrid, 28222, Spain

RECRUITING

HOSPITAL UNIVERSITARIO FUNDACION ALCORCON - Consulta de Hematología Hospital de Día Médico

Madrid, 28922, Spain

RECRUITING

HOSPITAL COSTA DEL SOL MARBELLA - Servicio de hematologia

Marbella, 29603, Spain

RECRUITING

HOSPITAL CENTRAL ASTURIAS - Servicio de Hematología

Oviedo, 33011, Spain

RECRUITING

HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia

Salamanca, 37007, Spain

RECRUITING

HOSPITAL CLINICO DE VALENCIA - Servicio de Hematologia

Valencia, 46010, Spain

RECRUITING

Oncology Institute of Southern Switzerland (IOSI) - Department of Oncology

Bellinzona, 6500, Switzerland

RECRUITING

Kantonsspital Graubunden - Departement Innere Medizin Medizinische Onkologie und Hämatologie

Chur, 7000, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève (HUG) - Hématologie

Geneva, 1205, Switzerland

RECRUITING

Kantonsspital Baselland - Zentrum Onkologie & Hämatologie

Liestal, 4410, Switzerland

WITHDRAWN

Kantonsspital Olten - Hämatologie

Olten, 4600, Switzerland

NOT YET RECRUITING

Spital STS AG - Onkologie und Hämatologiezentrum

Thun, 3600, Switzerland

RECRUITING

HFR Fribourg - Hématologie

Villars-sur-Glâne, 1752, Switzerland

RECRUITING

Stadtspital Zürich Triemli - Medizinische Onkologie und Hämatologie

Zurich, 8063, Switzerland

WITHDRAWN

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Lenalidomide; Rituximab; obinutuzumab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Butyrates; Acids, Acyclic; Benzimidazoles

Study Officials

• Franck MORSCHHAUSER

  Lymphoma Study Association

  PRINCIPAL INVESTIGATOR

• Christian BUSKE

  GLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne FAUGIER

CONTACT

+33 4 72 66 93 33; morninglyte@lysarc.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 28, 2024
• Study Start: June 7, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): April 1, 2034
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

FR (37); PT (1); ES (16); DE (37); BE (8); AU (9); CH (8)