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濾胞性リンパ腫におけるモスネツズマブとレナリドミドの抗CD20抗体+化学療法との比較FLIPI2-5の研究 (MorningLyte)

2026年9月24日 更新者：The Lymphoma Academic Research Organisation

未治療のFLIPI 2-5濾胞性リンパ腫患者における抗CD20モノクローナル抗体＋化学療法と比較したモスネツズマブ＋レナリドマイドの有効性と安全性を評価する第III相無作為化非盲検国際多施設共同研究

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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 Follicular Lymphoma International Prognostic Index (FLIPI) 2-5 follicular lymphoma This study is composed of a screening period (up to 6 weeks before randomization, i.e., 42 days), a treatment period (30 months i.e., 125w), a safety follow-up period (90 days i.e., 3 months), and a survival follow-up period (up to 7 years after the last randomized patient). The enrollment will last approximately 34 months. The total duration of the study will be therefore approximately 10 years.

Once a patient provides written consent, they may enter the screening phase, with a duration up to 6 weeks prior to randomization and initiation of treatment.

Upon completion of the required assessments in the screening phase, and fulfillment of the eligibility criteria, patients will be randomized. Investigators will be requested to indicate their treatment choice among permitted immuno-chemotherapy regimens just before randomization.

The treatment period for each patient starts with the first intake. The patients will receive protocol-specified treatments until:

  • inability to achieve a response at the end of induction phase (at M12 evaluation for experimental arm, and at M6 evaluation for control arms),
  • relapse or progression of the disease,
  • withdrawal of consent,
  • or unacceptable toxicity

In the experimental arm, patients will be treated for 1 cycle of 3 weeks for mosunetuzumab and then 11 cycles of 4 weeks for mosunetuzumab and lenalidomide (47 weeks, around 11 months) during the induction phase, and for a maximum of 9 additional cycles of 8 weeks during the maintenance phase (72 weeks, around 17 months), up to around 125 weeks (30 months). Patients should start the maintenance phase 7 to 8 weeks after the start of last induction cycle (C12).

In the control arm, patients will be treated for 8 or 6 cycles of 3 or 4 weeks for anti-CD20 mAb +cyclophosphamide-doxorubicine-vincristine-prednisone (CHOP) or anti-CD20 mAb + Bendamustine, respectively, depending on the assigned arm (24 weeks, around 5 months) during the induction phase, and for a maximum of 12 additional cycles of 8 weeks during the maintenance phase (96 weeks, around 22 months), up to around 125 weeks (30 months). Patients should start the maintenance phase, 6 to 7 or 7 to 8 weeks after the start of last induction cycle (C8 or C6).

The option to cross-over from the control arm to the experimental arm is not allowed.

All randomized patients will be followed for progression-free survival and overall survival using the same schedule. Patients will be followed up from End of treatment evaluation every 3 months during the first two years, then every 6 months during the next 3 years, then yearly until the end of study.

The end of study will occur when all randomized patients have been followed-up for survival for at least 7 years (or discontinued study early).

研究の種類

介入

入学 (推定)

790

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • オーストリア
      • Graz、オーストリア、8020
        • Krankenhaus der Barmherzigen Brüder Graz - Abteilung Für Innere Medizin I
      • Krems、オーストリア、3500
        • Krems University Hospital - Abteilung Für Innere Medizin 2
      • Leoben、オーストリア、8700
        • LKH HOCHSTEIERMARK - Department für Hämato-Onkologie
      • Linz、オーストリア、4021
        • Kepler Universitaetsklinikum - Univ.-Klinik für Hämatologie und Internistische Onkologie
      • Salzburg、オーストリア、5020
        • Paracelsus Medical University - 3rd Medical Department
      • Sankt Pölten、オーストリア、3100
        • Univ. Klinikum ST.PÖLTEN - Klinische Abteilung Für Innere Medizin 1
      • Vienna、オーストリア、1090
        • Medical University of Vienna - Department of Hematology and Hemostaseology
      • Wels、オーストリア、4600
        • Klinikum Wels-Grieskirchen GMBH - IVth Internal Department
  • スイス
      • Bellinzona、スイス、6500
        • Oncology Institute of Southern Switzerland (IOSI) - Department of Oncology
      • Chur、スイス、7000
        • Kantonsspital Graubunden - Departement Innere Medizin Medizinische Onkologie und Hämatologie
      • Geneva、スイス、1205
        • Hôpitaux Universitaires de Genève (HUG) - Hématologie
      • Olten、スイス、4600
        • Kantonsspital Olten - Hämatologie
      • Thun、スイス、3600
        • Spital STS AG - Onkologie und Hämatologiezentrum
      • Villars-sur-Glâne、スイス、1752
        • HFR Fribourg - Hématologie
  • スペイン
      • Albacete、スペイン、02006
        • HOSPITAL UNIVERSITARIO DE ALBACETE-Servicio de Hematologia
      • Barcelona、スペイン、08908
        • HOSPITAL DURAN I REYNALS - ICO Oncologia
      • Barcelona、スペイン、8025
        • HOSPITAL DE LA SANTA CREU I SANT PAU - Servicio de Hematología
      • Barcelona、スペイン、8035
        • HOSPITAL VALL D'HEBRON - Hematology Service
      • Barcelona、スペイン、8036
        • HOSPITAL CLINIC BARCELONA - Hematology department
      • Las Palmas de Gran Canaria、スペイン、35010
        • HOSPITAL UNIVERSITARIO DR. NEGRIN-Servicio de Hematologia
      • Lleida、スペイン、25198
        • HOSPITAL UNIVERSITARIO ARNAU DE VILANOVA - Servicio Hematologia
      • Madrid、スペイン、28006
        • HOSPITAL UNIVERSITARIO DE LA PRINCESA - Hematología
      • Madrid、スペイン、28007
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON - Servicio de Hematología-UTMO
      • Madrid、スペイン、28041
        • HOSPITAL 12 DE OCTUBRE - Servicio de Hematología y Hemoterapia
      • Madrid、スペイン、28222
        • HOSPITAL PUERTA DEL HIERRO - Servicio Hematologia
      • Madrid、スペイン、28922
        • HOSPITAL UNIVERSITARIO FUNDACION ALCORCON - Consulta de Hematología Hospital de Día Médico
      • Marbella、スペイン、29603
        • HOSPITAL COSTA DEL SOL MARBELLA - Servicio de hematologia
      • Oviedo、スペイン、33011
        • HOSPITAL CENTRAL ASTURIAS - Servicio de Hematología
      • Salamanca、スペイン、37007
        • HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia
      • Valencia、スペイン、46010
        • HOSPITAL CLINICO DE VALENCIA - Servicio de Hematologia
  • ドイツ
      • Amberg、ドイツ、92224
        • GESUNDHEITSZENTRUM ST. MARIEN GMBH - Hämatologie/Onkologie
      • Bamberg、ドイツ、96049
        • SOZIALSTIFTUNG BAMBERG - KLINIKUM AM BRUDERWALD - Hämatologie und internistische Onkologie
      • Berlin、ドイツ、10967
        • VIVANTES KLINIKUM AM URBAN - Hämatologie und Onkologie
      • Berlin、ドイツ、13125
        • Helios Klinikum Berlin-Buch - Klinik für Hämatologie und Stammzelltransplantation
      • Berlin、ドイツ、13353
        • CHARITE UNIVERSITATSMEDIZIN BERLIN - Med. Klinik m. S. Hämatologie, Onkologie, Tumorimmunologie
      • Bremen、ドイツ、28205
        • KLINIKUM BREMEN-MITTE - Gesundheit Nord gGmbH - Hämatologisch-Onkologische Tagesklinik
      • Chemnitz、ドイツ、9116
        • KLINIKUM CHEMNITZ GGMBH - Klinik f. Innere Medizin III
      • Düsseldorf、ドイツ、40225
        • UNIVERSITÄTSKLINIK DÜSSELDORF-Klinik für Hämatologie, Onkologie und Klinische Immunologie
      • Frankfurt、ドイツ
        • GOETHE UNIVERSITÄT FRANKFURT - Medizinische Klinik II Onkologie
      • Freiburg im Breisgau、ドイツ、79106
        • MEDICAL CENTER - UNIVERSITY OF FREIBURG - Klinik für Innere Medizin I Hämatologie, Onkologie und Stammzelltransplantation
      • Göttingen、ドイツ、37075
        • GEORG-AUGUST-UNIV, GOETTINGEN - Klinik fur Haematologie und Medizinisched Onkologie
      • Halle、ドイツ、6097
        • UNIVERSITATSKLINIKUM HALLE (SAALE) - Klinik für Innere Medizin IV
      • Hanover、ドイツ、30459
        • KLINIKUM REGION HANNOVER GMBH KLINIK FÜR HÄMATOLOGIE-Onkologie und immunologie
      • Heidelberg、ドイツ、69120
        • UNIVERSITÄTSKLINIKUM HEIDELBERG - Innere Medizin V
      • Homburg、ドイツ、66421
        • Universitätsklinikum des Saarlandes - Klinik für Innere Medizin I - Onkologie, Hämatol. Immun. & Rheumatololgie
      • Jena、ドイツ、07747
        • UNIVERSITÄTSKLINIKUM JENA-Klinik für Innere Medizin II
      • Kaiserslautern、ドイツ、67655
        • WESTPFALZ KLINIKUM - Klinik für Innere Medizin I
      • Kiel、ドイツ、24105
        • UKSH UNIVERSITAETSKLINIKUM SCHLESWIG-HOLSTEIN - Med. Klinik II - Hämatologie und Onkologie
      • Koblenz、ドイツ、56073
        • GEMEINSCHAFTSKLINIKUM MITTELRHEIN GGMBH - Innere Medizin - Hämatologie/Onkologie
      • Landshut、ドイツ、84036
        • LAKUMED KLINIKUM - Onkologisches und palliativmedizinisches Netzwerk Landshut
      • Lübeck、ドイツ、23538
        • UNIVERSITATSKLINIKUM LUBECK - Klinik für Hämatologie und Onkologie
      • Mönchengladbach、ドイツ、41063
        • KLINIKEN MARIA HILF GMBH KRANKENHAUS ST. FRANZISK - Hämatologie, Onkologie & Gastroenterologie
      • München、ドイツ、81377
        • KLINIKUM GROSSHADERN DER LMU MUNCHEN - Hämatologie und Onkologie allgemein
      • München、ドイツ、81675
        • KLINIKUM RECHTS DER ISAR, III MED KLINIK DER TU - Hämatologie und Onkologie
      • Münster、ドイツ、48149
        • Gemeinschaftspraxis Fur Hamatologie Und Onkologie
      • Münster、ドイツ、48149
        • Universtatsklinikum Munster
      • Paderborn、ドイツ、33098
        • BRUEDERKRANKENHAUS ST. JOSEF PADERBORN - Klinik für Hämatologie und Onkologie
      • Ravensburg、ドイツ、86212
        • MVZ FÜR HÄMATOLOGIE UND ONKOLOGIE RAVENSBURG GMBH - Hematology
      • Regensburg、ドイツ、93053
        • UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III
      • Reutlingen、ドイツ、72764
        • KLINIKUM AM STEINENBERG REUTLINGEN GMBH - Medizinische Klinik I
      • Rostock、ドイツ、18057
        • UNIVERSITÄT ROSTOCK - Hämatologie/Onkologie
      • Rotenburg (Wümme)、ドイツ、27356
        • AGAPLESION DIAKONIEKLINIKUM ROTENBURG - Klinik für Hämatologie, Onkologie und Nephrologie
      • Ulm、ドイツ、89081
        • UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie
      • Wuppertal、ドイツ、42283
        • HELIOS UNIVERSITÄTSKLINIKUM WUPPERTAL - Hämatologie und Onkologie
      • Würzburg、ドイツ、97080
        • UNIVERSITY WURZBURG - Hämatologie
  • フランス
      • Avignon、フランス、84000
        • CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie
      • Bayonne、フランス、64100
        • CH DE LA COTE BASQUE - Service Hématologie
      • Besançon、フランス、25030
        • CHU JEAN MINJOZ - Service Hématologie
      • Bordeaux、フランス、33076
        • INSTITUT BERGONIE - Service d'Oncologie Médicale
      • Cahors、フランス、46005
        • CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie
      • Chambéry、フランス、73011
        • CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie
      • Clermont-Ferrand、フランス、63003
        • CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique
      • Créteil、フランス、94010
        • HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes
      • Dijon、フランス、21000
        • CHU DIJON BOURGOGNE - Service Hématologie Clinique
      • La Roche-sur-Yon、フランス、85925
        • CHD DE VENDEE - Service Hématologie
      • La Tronche、フランス、38700
        • CHU DE GRENOBLE - Service Hématologie
      • Lille、フランス、59020
        • HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie
      • Lille、フランス、59037
        • CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie
      • Limoges、フランス、87042
        • CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire
      • Marseille、フランス、13273
        • INSTITUT PAOLI CALMETTES - Service Hématologie
      • Montpellier、フランス、34090
        • CHU DE MONTPELLIER - Département d'Hématologie Clinique
      • Mulhouse、フランス、68100
        • GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie
      • Nantes、フランス、44093
        • CHU DE NANTES - Service Hématologie
      • Niort、フランス、79021
        • CENTRE HOSPITALIER DE NIORT - Médecine interne
      • Paris、フランス、75475
        • HOPITAL SAINT-LOUIS - Service Hématologie
      • Pessac、フランス、33604
        • CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire
      • Pierre-Bénite、フランス、69495
        • CHU LYON-SUD - Hématologie
      • Poissy、フランス、78303
        • CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie
      • Poitiers、フランス、86021
        • CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire
      • Pringy、フランス、74374
        • CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie
      • Reims、フランス、57092
        • CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie
      • Rennes、フランス、35033
        • CHU PONTCHAILLOU - Hématologie Clinique
      • Rouen、フランス、76038
        • CENTRE HENRI BECQUEREL - Service Hématologie
      • Saint-Cloud、フランス、92210
        • INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie
      • Saint-Priest-en-Jarez、フランス、42270
        • Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie
      • Strasbourg、フランス、67033
        • INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique
      • Toulouse、フランス、31059
        • IUCT ONCOPOLE - Service Hématologie
      • Tours、フランス、37044
        • CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire
      • Valenciennes、フランス、59322
        • CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie
      • Vandœuvre-lès-Nancy、フランス、54511
        • CHU BRABOIS - Service Hématologie
      • Vannes、フランス、56017
        • CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie
      • Villejuif、フランス、94085
        • GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique
  • ベルギー
      • Bruges、ベルギー、8000
        • AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie
      • Brussels、ベルギー、1070
        • INSTITUT JULES BORDET - Service Hématologie
      • Brussels、ベルギー、1200
        • UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie
      • Charleroi、ベルギー、6000
        • GRAND HOPITAL DE CHARLEROI - Service Hématologie
      • Ghent、ベルギー、9000
        • UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie
      • La Louvière、ベルギー、7100
        • HELORA - Hôpital de La Louvière - Site Jolimont - Service Hématologie Clinique
      • Liège、ベルギー、4000
        • CHU DE LIEGE - Service Hématologie
      • Yvoir、ベルギー、5530
        • CHU UCL NAMUR - SITE GODINNE - Service Hématologie
  • ポルトガル
      • Lisbon、ポルトガル、1099
        • INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. 1. 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.

  2. FLIPI 2-5.

  3. All Ann Arbor stages (including stage I if FLIPI ≥ 2).

  4. Must need treatment as evidenced by at least one of the following criteria:

    4.1. 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

  5. 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).

  6. Participant who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures.

  7. Must be ≥ 18 years old at the time of signing the informed consent form (ICF).

  8. ECOG performance status 0 to 2.

  9. Estimated minimum life expectancy of 3 months.

  10. Adequate hematological function within 28 days prior to randomization, including:

    10.1. 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)

  11. Normal laboratory values:

    11.1. 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

  12. LVEF within normal range (i.e. > 50% as evaluated by Transthoracic Echocardiography or > 45% as evaluated by isotopic method (MUGA scan).

  13. Participants should be able to receive adequate prophylaxis and/or therapy for thromboembolic events (aspirin, low molecular weight heparin or direct oral anticoagulants).

    Patients with a curative anticoagulation therapy can be enrolled. A patient with deep vein thrombosis due to compressive syndrome is eligible if a curative anticoagulation therapy has been started at least 1 week before initiating study treatment: low molecular weight heparin possible at treatment onset, then direct oral anticoagulants according to local practices.

  14. Must be able to adhere to the study visit schedule and other protocol requirements.

  15. No more applicable following SM#14

  16. Negative HIV test before randomization, with the following exception:

    Patients with a positive HIV test before randomization are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.

  17. For women of childbearing potential (WOCBP) :

    • must have a negative result for pregnancy test (highly sensitive serum) within 7 days before randomization and within 7 days before initiation of study treatment.
    • must agree to abstain from becoming pregnant or breastfeeding, and agree to use highly effective contraceptive methods during study participation, and for at least 28 days after the final dose of lenalidomide (if applicable), 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable), 12 months after the final dose of CHOP (if applicable), 6 months after the final dose of bendamustine (if applicable), 12 months after the final dose of rituximab (if applicable), and 18 months after the final dose of obinutuzumab (if applicable).

  18. For men with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period (including periods of treatment interruption), and for at least 07 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of CHOP (if applicable), 3 months after the final dose of bendamustine (if applicable), 12 months after the final dose of rituximab (if applicable), and 3 months after the final dose of obinutuzumab (if applicable). Men must also agree to refrain from donating sperm from the first day of treatment until at least 7 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of CHOP (if applicable), 3 months after the final dose of bendamustine (if applicable), 12 months after the final dose of rituximab (if applicable), and 3 months after the last dose of obinutuzumab (if applicable).

  19. Participant covered by any social security system (France).

  20. Participant who understands and speaks one of the country official languages, unless local regulation authorizes independent translators.

Exclusion criteria:

  1. Grade 3b follicular lymphoma according to the WHO 2016 classification12, or follicular large B-cell lymphoma according to the WHO 2022 classification13

  2. 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.

  3. Prior localized radiotherapy for the FL.

  4. Prior history of another lymphoma.

  5. 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.

  6. 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.

  7. 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.

  8. Use of any standard or experimental anti-cancer drug therapy within 45 days of the start (Day 1) of study treatment.

  9. Any contraindication to any drug contained in the study treatment control arms or in the Auxiliary Medicinal Products (AxMPs)

  10. 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

  11. 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.

  12. Major surgery (excluding surgical documentation of FL) within 28 days prior to signing informed consent.

  13. Seropositive for or active viral infection with hepatitis B virus (HBV):

    • HBsAg positive
    • HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA (Patients who are HBsAg negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative are eligible. They should be treated and perform testing at regular interval described in section Anti infectious prophylaxis; Patients who are seropositive due to a history of hepatitis B vaccine (anti-HBs positive) are eligible).

  14. Known seropositive for, or active infection hepatitis C virus (HCV) (Patients who are positive for HCV antibody with a negative viral RNA are eligible).

  15. Known or suspected hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab, anti-CD20 mAb, tocilizumab, lenalidomide formulation, including mannitol; or to any of the excipients.

  16. History of solid organ transplantation or allogeneic stem cell transplant (SCT).

  17. Active autoimmune disease requiring treatment.

  18. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, uveitis, or glomerulonephritis.

    • Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
    • Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
    • Participants with a remote history of, or well-controlled autoimmune disease, with a treatment-free interval from immunosuppressive therapy for 12 months may be eligible after review and discussion with the Coordinating investigator.

  19. Participants with any active infection such as known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds), known or suspected chronic active Epstein-Barr virus (EBV) infection are excluded.

  20. Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to:

    • significant cardiovascular disease [e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure | American Heart Association), myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina)
    • significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
    • clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
    • current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed. Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible.

  21. History of confirmed progressive multifocal leukoencephalopathy (PML).

  22. Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).

  23. History of erythema multiforme, Grade ≥3 rash, or blistering rash following prior treatment with immunomodulatory derivatives.

  24. History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis.

  25. Active malignancy other than the one treated in this research. Prior history of malignancies unless the patient has been free of the disease and therapy for ≥ 3 years. However, patients with a single occurrence of the following conditions that have been treated with curative intent are eligible:

    • Localized non-melanoma skin cancer.
    • Carcinoma in situ of the cervix.
    • Carcinoma in situ of the breast.
    • Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor Node Metastasis [TNM] staging system) or prostate cancer.

  26. Presence or history of CNS or meningeal involvement by lymphoma.

  27. Pregnant, planning to become pregnant or lactating WOCBP.

  28. Any significant medical conditions, including the presence of laboratory abnormality or psychiatric illness which places the patient at unacceptable risk if he/she were to participate in the study, and likely to interfere with participation in this clinical study (according to the investigator's decision) or which confounds the ability to interpret data from the study.

  29. Person deprived of his/her liberty by a judicial or administrative decision.

  30. Person hospitalized without consent.

  31. Adult person under legal protection.

  32. Patients with absolute lymphocyte count > 20 G/L before randomization. Participants circulating lymphoma cell≥ 5 G/L must be discussed with the Sponsor before randomization.

NB: for 29-31., if there is an individual benefit for such patients, an Ethics Committee will have to be informed case by case.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Mosun-Len

Mosunetuzumab + lenalidomide
薬：Mosunetuzumab

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

薬：Lenalidomide

Lenalidomide starting dose is based on patient's creatinine clearance. Day 1 to Day 21 from C2 to C12
アクティブコンパレータ：R-CHOP

Rituximab-CHOP
薬：Rituximab

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

薬：Cyclophosphamide

750 mg/m2 Day 1 from C1 to C6

薬：Doxorubicin

50 mg/m2 Day 1 from C1 to C6

薬：Vincristin

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

薬：Prednisone

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

薬：Rituximab

when associated to bendamustin IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2 to C6 Day 1 from C7 to C18
アクティブコンパレータ：G-CHOP

Obinutuzumab-CHOP
薬：Cyclophosphamide

750 mg/m2 Day 1 from C1 to C6

薬：Doxorubicin

50 mg/m2 Day 1 from C1 to C6

薬：Vincristin

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

薬：Prednisone

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

薬：Obinutuzumab

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

薬：Obinutuzumab

when associated to bendamustin 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from C9 to C20
アクティブコンパレータ：R-Benda

Rituximab-Bendamustin
薬：Rituximab

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

薬：Rituximab

when associated to bendamustin IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2 to C6 Day 1 from C7 to C18

薬：Bendamustin

90 mg/m2 Day 1 and Day 2 from C1 to C6
アクティブコンパレータ：G-Benda

Obinutuzumab-Bendamustin
薬：Obinutuzumab

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

薬：Obinutuzumab

when associated to bendamustin 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from C9 to C20

薬：Bendamustin

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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Progression Free Survival (PFS)
時間枠：130 PFS events assessed by an Independent Review Committee (IRC) (4.6 years)

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)
時間枠：173 PFS events assessed by IRC (5.8 y)

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)

二次結果の測定

結果測定
メジャーの説明
時間枠
重篤な特別有害事象（SAE および AESI）を含む有害事象（AE）の発生率と重症度
時間枠：4.6年
4.6年
SAEおよびAESIを含むAEの発生率と重症度
時間枠：5.8年
5.8年
忍容性（投与量の中断、遅延、投与量の減量、および研究治療の中止の発生率によって評価）
時間枠：4.6年
4.6年
忍容性（投与量の中断、遅延、投与量の減量、および研究治療の中止の発生率によって評価）
時間枠：5.8年
5.8年
二次原発性悪性腫瘍 (SPM) の発生率
時間枠：4.6年
4.6年
二次原発性悪性腫瘍 (SPM) の発生率
時間枠：5.8年
5.8年
モスネツズマブに対する抗薬物抗体（ADA）
時間枠：各サイクル、18 か月、24 か月、30 か月
各サイクル、18 か月、24 か月、30 か月
モスネツズマブの最大血清濃度 - Cmax
時間枠：各サイクル、18 か月、24 か月、30 か月
各サイクル、18 か月、24 か月、30 か月
モスネツズマブの最小血清濃度 - Cmin
時間枠：各サイクル、18 か月、24 か月、30 か月
各サイクル、18 か月、24 か月、30 か月
モスネツズマブの血清濃度の曲線下面積 - AUC
時間枠：各サイクル、18 か月、24 か月、30 か月
各サイクル、18 か月、24 か月、30 か月
レナリドマイドの最大血清濃度 - Cmax
時間枠：各サイクル、18 か月、24 か月、30 か月
各サイクル、18 か月、24 か月、30 か月
レナリドマイドの最小血清濃度 - Cmin
時間枠：各サイクル、18 か月、24 か月、30 か月
各サイクル、18 か月、24 か月、30 か月
レナリドマイドの血清濃度の曲線下面積 - AUC
時間枠：各サイクル、18 か月、24 か月、30 か月
各サイクル、18 か月、24 か月、30 か月
Overall Response (OR)
時間枠：6 months

by Lugano 2014 (PET-CT based response), assessed by investigator and IRC
6 months
Complete Metabolic Rate (CMR)
時間枠：6 months

by Lugano 2014 (PET-CT based response), assessed by investigator and IRC
6 months
Overall Response (OR)
時間枠：12 months

by Lugano 2014 (PET-CT based response), assessed by investigator and IRC
12 months
Complete Metabolic Rate (CMR)
時間枠：12 months

by Lugano 2014 (PET-CT based response), assessed by investigator and IRC
12 months
Overall Response (OR) and Complete Response (CR) rate at EOT
時間枠：4.6 years

by Lugano 2014 (PET-CT based response), assessed by investigator and IRC
4.6 years
Best Overall Response (CR or PR) rate
時間枠：5.8 years

by Lugano 2014 (PET-CT based response), assessed by investigator and IRC
5.8 years
Progression of disease within 2 years (POD24)
時間枠：2 years

rate of progression of disease (POD) within 2 years of first line therapy
2 years
PFS
時間枠：4.6 years

by Lugano 2014, assessed by investigator
4.6 years
PFS
時間枠：5.8 years

by Lugano 2014, assessed by investigator
5.8 years
Event Free Survival (EFS) by Lugano 2014
時間枠：4.6 years

time between randomization and date of first documented disease progression/relapse, initiation of a new anti-lymphoma treatment or death from any cause
4.6 years
Event Free Survival (EFS) by Lugano 2014
時間枠：5.8 years

time between randomization and date of first documented disease progression/relapse, initiation of a new anti-lymphoma treatment or death from any cause
5.8 years
Time to Next Anti-Lymphoma Treatment (TTNLT)
時間枠：4.6 years

time between randomization and date of first documented administration of any new anti-lymphoma treatment
4.6 years
Time to Next Anti-Lymphoma Treatment (TTNLT)
時間枠：5.8 years

time between randomization and date of first documented administration of any new anti-lymphoma treatment
5.8 years
Duration of response
時間枠：4.6 years

defined for patients with a best overall response of CR or PR determined by Lugano 2014 (PET-CT based response), defined as the time of 1st occurrence of CR or PR to disease progression/relapse or death from any cause
4.6 years
Duration of response
時間枠：5.8 years

defined for patients with a best overall response of CR or PR determined by Lugano 2014 (PET-CT based response), defined as the time of 1st occurrence of CR or PR to disease progression/relapse or death from any cause
5.8 years
Overall Response (OR)
時間枠：End of treatment (12 months for experimental arm, 6 months for comparative arms)

assessed by investigator and IRC
End of treatment (12 months for experimental arm, 6 months for comparative arms)
Duration of complete response
時間枠：4.6 years

for patients with a best overall response of CR determined by Lugano 2014 (PET-CT based response), define as the time of first occurrence of CR to disease progression/relapse or death from any cause
4.6 years
Duration of complete response
時間枠：5.8 years

for patients with a best overall response of CR determined by Lugano 2014 (PET-CT based response), define as the time of first occurrence of CR to disease progression/relapse or death from any cause
5.8 years
Overall Survival (OS)
時間枠：4.6 years

time from randomization to death from any cause
4.6 years
Overall Survival (OS)
時間枠：5.8 years

time from randomization to death from any cause
5.8 years
Time to deterioration in physical functioning
時間枠：baseline, 6 months, 12 months, 18 months, 24 months, 30 months or end of treatment

EORTC QLQ-C30 quality of life questionnaire
baseline, 6 months, 12 months, 18 months, 24 months, 30 months or end of treatment
Time to deterioration in lymphoma symptoms
時間枠：baseline, 6 months, 12 months, 18 months, 24 months, 30 months or end of treatment

FACTLym LYMS quality of life questionnaire
baseline, 6 months, 12 months, 18 months, 24 months, 30 months or end of treatment

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

The Lymphoma Academic Research Organisation

協力者

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Lymphoma Study Association
Swiss Cancer Institute

捜査官

  • 主任研究者：Franck MORSCHHAUSER、Lymphoma Study Association
  • 主任研究者：Christian BUSKE、GLA

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年6月7日

一次修了 (推定)

2028年11月1日

研究の完了 (推定)

2034年4月1日

試験登録日

最初に提出

2024年2月14日

QC基準を満たした最初の提出物

2024年2月21日

最初の投稿 (実際)

2024年2月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月25日

QC基準を満たした最後の更新が送信されました

2026年9月24日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • MorningLyte

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

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