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여포성 림프종 FLIPI2-5에서 항CD20 항체 + 화학요법과 Mosunetuzumab + Lenalidomide의 비교 연구 (MorningLyte)

2026년 9월 24일 업데이트: The Lymphoma Academic Research Organisation

이전에 치료받지 않은 FLIPI 2-5 여포성 림프종 환자를 대상으로 항-CD20 단클론 항체 + 화학요법과 비교하여 모수네투주맙 + 레날리도마이드의 효능 및 안전성을 평가하는 무작위 배정, 공개, 국제, 다기관 연구 3상

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (추정된)

790

단계

  • 3단계

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연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Mosun-Len

Mosunetuzumab + lenalidomide
의약품: 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

의약품: Lenalidomide

Lenalidomide starting dose is based on patient's creatinine clearance. Day 1 to Day 21 from C2 to C12
활성 비교기: R-CHOP

Rituximab-CHOP
의약품: 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

의약품: Cyclophosphamide

750 mg/m2 Day 1 from C1 to C6

의약품: Doxorubicin

50 mg/m2 Day 1 from C1 to C6

의약품: Vincristin

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

의약품: Prednisone

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

의약품: 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
활성 비교기: G-CHOP

Obinutuzumab-CHOP
의약품: Cyclophosphamide

750 mg/m2 Day 1 from C1 to C6

의약품: Doxorubicin

50 mg/m2 Day 1 from C1 to C6

의약품: Vincristin

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

의약품: Prednisone

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

의약품: 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

의약품: 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
활성 비교기: R-Benda

Rituximab-Bendamustin
의약품: 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

의약품: 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

의약품: Bendamustin

90 mg/m2 Day 1 and Day 2 from C1 to C6
활성 비교기: G-Benda

Obinutuzumab-Bendamustin
의약품: 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

의약품: 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

의약품: Bendamustin

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival (PFS)
기간: 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)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
심각한 AE(SAE 및 AESI)를 포함한 부작용(AE)의 발생률 및 심각도
기간: 4.6년
4.6년
SAE 및 AESI를 포함한 AE의 발생률 및 심각도
기간: 5.8년
5.8년
용량 중단, 지연, 용량 감소 및 연구 치료 중단의 발생률로 평가된 내약성
기간: 4.6년
4.6년
용량 중단, 지연, 용량 감소 및 연구 치료 중단의 발생률로 평가된 내약성
기간: 5.8년
5.8년
2차 원발성 악성종양(SPM)의 발생률
기간: 4.6년
4.6년
2차 원발성 악성종양(SPM)의 발생률
기간: 5.8년
5.8년
모수네투주맙에 대한 항약물 항체(ADA)
기간: 각 주기, 18개월, 24개월, 30개월
각 주기, 18개월, 24개월, 30개월
모수네투주맙의 최대 혈청 농도 - Cmax
기간: 각 주기, 18개월, 24개월, 30개월
각 주기, 18개월, 24개월, 30개월
모수네투주맙의 최소 혈청 농도 - Cmin
기간: 각 주기, 18개월, 24개월, 30개월
각 주기, 18개월, 24개월, 30개월
모수네투주맙의 혈청 농도 곡선 아래 면적 - AUC
기간: 각 주기, 18개월, 24개월, 30개월
각 주기, 18개월, 24개월, 30개월
레날리도마이드의 최대 혈청 농도 - Cmax
기간: 각 주기, 18개월, 24개월, 30개월
각 주기, 18개월, 24개월, 30개월
레날리도마이드의 최소 혈청 농도 - Cmin
기간: 각 주기, 18개월, 24개월, 30개월
각 주기, 18개월, 24개월, 30개월
레날리도마이드의 혈청 농도 곡선 아래 면적 - AUC
기간: 각 주기, 18개월, 24개월, 30개월
각 주기, 18개월, 24개월, 30개월
Overall Response (OR)
기간: 6 months

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

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

by Lugano 2014 (PET-CT based response), assessed by investigator and IRC
12 months
Complete Metabolic Rate (CMR)
기간: 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
기간: 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
기간: 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)
기간: 2 years

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

by Lugano 2014, assessed by investigator
4.6 years
PFS
기간: 5.8 years

by Lugano 2014, assessed by investigator
5.8 years
Event Free Survival (EFS) by Lugano 2014
기간: 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
기간: 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)
기간: 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)
기간: 5.8 years

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

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

time from randomization to death from any cause
5.8 years
Time to deterioration in physical functioning
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

The Lymphoma Academic Research Organisation

협력자

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

수사관

  • 수석 연구원: Franck MORSCHHAUSER, Lymphoma Study Association
  • 수석 연구원: Christian BUSKE, GLA

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 6월 7일

기본 완료 (추정된)

2028년 11월 1일

연구 완료 (추정된)

2034년 4월 1일

연구 등록 날짜

최초 제출

2024년 2월 14일

QC 기준을 충족하는 최초 제출

2024년 2월 21일

처음 게시됨 (실제)

2024년 2월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 24일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MorningLyte

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다