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: 5 countries
• Sites: 49

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 (36)

• Overall Response (OR)

  6 months

• Complete Metabolic Rate (CMR)

  6 months

• Overall Response (OR)

  12 months

• Complete Metabolic Rate (CMR)

  12 months

• Best Overall Response (CMR + PMR) rate

  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

20 mg/day 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:

• 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:
• a nodal or extranodal mass/lesion \> 7 cm in its largest diameter or,
• involvement of at least 3 nodal or extranodal sites (each with a diameter greater than \> 3 cm)
• Presence of at least one of the following B symptoms:
• fever (\> 38°C) of unclear etiology
• night sweats
• weight loss greater than 10% within the prior 6 months
• Symptomatic splenomegaly
• Any compressive syndrome (for example, but not restricted to- ureteral, orbital, gastrointestinal)
• Any one of the following cytopenias due to lymphoma:
• hemoglobin \< 10g/dL (6.25 mmol/L)
• platelets \<100 x 109/L, or

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.
• Prior localized radiotherapy for the FL.
• Prior history of another lymphoma.
• Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment within 48 hours (patients with controlled disease after adequate pleural/serous drainage and/or effective pleurX™ or similar system are eligible).
• Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure (patients with adequate management i.e. ureteral catheter or double J stent allowing renal failure control are eligible).
• Symptomatic lymphomatous epidural lesion (patients whose disease is controlled by neurosurgery or short course of steroids are eligible).
• Use of any standard or experimental anti-cancer drug therapy within 42 days of the start (Day 1) of study treatment.
• Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) or corticosteroid \> 1mg/kg/day prednisone or equivalent within 10 days prior to first dose of study treatment. Systemic corticosteroid treatment \< 20 mg/day of prednisone or equivalent, inhaled corticosteroids and mineralocorticoids for management of orthostatic hypotension is permitted. A single dose of dexamethasone for nausea or B symptoms is permitted.
• 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 5 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
• 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; Patients who are seropositive due to a history of hepatitis B vaccine (anti-HBs positive) are eligible).
• Known seropositive for, or active infection hepatitis C virus (HCV) (Patients who are positive for HCV antibody with a negative viral RNA are eligible).
• Known or suspected hypersensitivity to biopharmaceuticals produced in Chinese hamster ovarian (CHO) cells or any component of the mosunetuzumab, Anti-CD20 mAb, tocilizumab, lenalidomide formulation, including mannitol; or to any of the excipients.

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 (49)

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

CHU DE LIEGE - Service Hématologie

Liège, 4000, Belgium

RECRUITING

CHR VERVIERS - LA TOURELLE - Service Hématologie

Verviers, 4800, 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

UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III

Regensburg, 93053, Germany

RECRUITING

UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie

Ulm, 89081, Germany

RECRUITING

INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia

Lisbon, 1099, Portugal

RECRUITING

HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia

Salamanca, 37007, Spain

RECRUITING

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

Julie ASSEMAT

CONTACT

+33 (0)4 27 01 27 51; morninglyte@lysarc.org

Marion TAYOL

CONTACT

+33 (0)6 24 70 15 27; 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: October 15, 2024

Record last verified: 2024-10

Locations

FR (37); PT (1); ES (1); DE (2); BE (8)