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InMIND: A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

Sponsor
Incyte Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04680052
Collaborator
(none)
618
Enrollment
211
Locations
2
Arms
87.8
Anticipated Duration (Months)
2.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
618 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double Blind
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Actual Study Start Date :
Apr 15, 2021
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Aug 9, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A : tafasitamab + rituximab + lenalidomide

Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

Drug: tafasitamab
tafasitamab will be administered IV for 12 cycles
Other Names:
  • INCMOR00208
  • MOR00208

    • Drug: rituximab
    Rituximab will be administered IV on cycles 1 - 5

    Drug: lenalidomide
    Lenalidomide will be administered PO for 12 cycles
    Placebo Comparator: Arm B : placebo+rituximab+lenalidomide

    Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

    Drug: rituximab
    Rituximab will be administered IV on cycles 1 - 5

    Drug: lenalidomide
    Lenalidomide will be administered PO for 12 cycles

    Drug: placebo
    placebo will be administered IV for 12 cycles

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) in FL population [Up to 6 years]

      Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.

    Secondary Outcome Measures

    1. Progression Free Survival (PFS) in FL and MZL populations [Up to 6 years]

      Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.

    2. Complete Response in FL population [Up to 6 years]

      Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit

    3. Minimal Residual Disease-negativity rate in FL and MZL Population [14 months]

      Defined as less than 1 residual tumor cell per 10^4 normal cells in peripheral blood and bone marrow.

    4. Overall Survival in FL Population [Up to 6 years]

      Defined as survival from time of study randomization to death of any cause.

    5. Complete Response in Overall population [Up to 6 years]

      Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit

    6. Overall Survival in overall Population [Up to 6 years]

      Defined as survival from time of study initiation to death of any cause.

    7. Best Overall Response Rate in FL and overall population [Up to 6 years]

      Defined as proportion of participants whose best overall response was a complete response (CR) or partial response (PR).

    8. Duration of Response in FL and overall population [Up to 6 years]

      Defined as the time to the first response to evidence of progression.

    9. Quality-of-Life Assessments in FL and overall populations [Up to 6 years]

      Defined as a patient self evaluation questionnaire

    10. Safety: Number of participants with TEAE's [13 months]

      Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL

    • Willingness to avoid pregnancy or fathering children

    • In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)

    • Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy

    • Documented relapsed, refractory, or PD after treatment with systemic therapy

    • ECOG performance status of 0 to 2

    Exclusion Criteria:

    • Women who are pregnant or breastfeeding.

    • Any histology other than FL and MZL or clinical evidence of transformed lymphoma

    • Prior non-hematologic malignancy

    • Congestive heart failure

    • HCV positivity, chronic HBV infection or history of HIV infection

    • Active systemic infection

    • CNS lymphoma involvement

    • Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1

    • Prior use of lenalidomide in combination with rituximab

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 John Muir Health Clinical Research Center Concord California United States 94520-2266
    2 Marin Cancer Care Greenbrae California United States 94904
    3 Sharp Memorial Hospital San Diego California United States 92123
    4 The Oncology Institute of Hope and Innovation Whittier California United States 90603
    5 Middlesex Hospital Cancer Center Middletown Connecticut United States 06457
    6 Smilow Cancer Hospital New Haven Connecticut United States 06510
    7 Cancer Specialists of North Florida Jacksonville Florida United States 32256
    8 Brcr Medical Center, Inc Plantation Florida United States 33322
    9 Asclepes Research Centers Weeki Wachee Florida United States 34607
    10 Northwest Georgia University Marietta Georgia United States 30060
    11 Straub Medical Center Honolulu Hawaii United States 96813
    12 Des Moines Oncology Research Association Des Moines Iowa United States 50309
    13 Norton Cancer Institute Louisville Kentucky United States 40207
    14 Tulane University New Orleans Louisiana United States 70112
    15 University of Maryland - Greenebaum Cancer Center Baltimore Maryland United States 21201
    16 Cancer Center For Blood Disorders Bethesda Maryland United States 20817
    17 Barbara Ann Karmanos Cancer Hospital Detroit Michigan United States 48201
    18 Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc) Saint Louis Park Minnesota United States 55416
    19 Hattiesburg Clinic Hematology Hattiesburg Mississippi United States 39401
    20 Roswell Park Cancer Institute Buffalo New York United States 14263
    21 Nyu Clinical Cancer Center New York New York United States 10016
    22 Levine Cancer Institute Charlotte North Carolina United States 28204
    23 Integris Cancer Institute Oklahoma City Oklahoma United States 73142
    24 Charleston Hematology Oncology Associates Charleston South Carolina United States 29414
    25 Prisma Health Upstate Greenville South Carolina United States 29615
    26 Prairie Lakes Health Care System, Inc. Watertown South Dakota United States 57201
    27 Texas Oncology-Baylor Charles A. Sammons Dallas Texas United States 75246
    28 The Center For Cancer and Blood Disorders Fort Worth Texas United States 76104
    29 Lyndon B Johnson General Hospital Houston Texas United States 77030
    30 Md Anderson Cancer Center Houston Texas United States 77030
    31 Renovatio Clinical Spring Texas United States 77380
    32 Utah Cancer Specialists Salt Lake City Utah United States 84106
    33 University of Virginia Medical Center Charlottesville Virginia United States 22908
    34 Vista Oncology Inc Ps Olympia Washington United States 98506
    35 Virginia Mason Medical Center Seattle Washington United States 98101
    36 University of Washington - Seattle Cancer Care Alliance Seattle Washington United States 98109-4405
    37 Northwest Medical Specialties Pllc Tacoma Washington United States 98405
    38 St George Hospital Kogarah New South Wales Australia 02217
    39 Liverpool Hospital Sydney New South Wales Australia 02170
    40 Wollongong Hospital - Illawarra Regional Hospital Wollongong New South Wales Australia 02500
    41 Gold Coast Hospital Southport Queensland Australia 04215
    42 Royal Adelaide Hospital Adelaide South Australia Australia 05000
    43 Flinders Medical Centre Bedford Park South Australia Australia 05042
    44 The Alfred Hospital Melbourne Victoria Australia 03004
    45 Northern Hospital Melbourne Victoria Australia 03076
    46 Western Health St. Albans Victoria Australia 03021
    47 Perth Blood Institute West Perth Western Australia Australia 06005
    48 Eastern Health Box Hill Australia 3128
    49 Royal Hobart Hospital Hobart Australia 07000
    50 Innsbruck University Hospital Innsbruck Austria 06020
    51 Kepler Universitat Klinikum Linz Austria 04020
    52 Medizinische Universitat Wien Allgemeines Krankenhaus Der Stadt Wien Wien Austria 01090
    53 Zna Stuivenberg Antwerpen Belgium 02060
    54 A.Z. St.-Jan-Dienst Hematologie Brugge Belgium 8000
    55 Institut Jules Bordet Brussels Belgium 01000
    56 Cliniques Universitaires Ucl Saint-Luc Brussels Belgium 01200
    57 Universitair Ziekenhuis Antwerpen, Dienst Hematologie Edegem Belgium 2650
    58 Ghent University Hospital Gent Belgium 09000
    59 Universitair Ziekenhuis (Uz) Leuven Leuven Belgium 03000
    60 Centre Hospitalier Universitaire de Liege - Sart Tilman Liege Belgium 04000
    61 AZ Delta Roeselare Belgium 8800
    62 Chu Ucl Namur University Hospital Mont-Godinne Yvoir Belgium 05530
    63 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    64 British Columbia Cancer Agency Vancouver British Columbia Canada V5Z 1L3
    65 London Health Sciences Centre London Ontario Canada N6A 5W9
    66 Hospital Maisonneuve Rosemont Montreal Quebec Canada H1T 2M4
    67 McGill University Jewish General Hospital Montreal Quebec Canada H3T 1E2
    68 Chu de Quebec - Universite Laval (Chul) Quebec Canada G1J 1Z4
    69 University Brno Czechia 62500
    70 University Hospital Hradec Kralove Hradec Kralove Czechia 50333
    71 University Hospital Ostrava Ostrava Czechia 70800
    72 Vseobecna Fakultni Nemocnice Prague Czechia 128 08
    73 University Hospital Kralovkse Vinohrady Praha Czechia 10034
    74 University Hospital Motol Praha Czechia 15000
    75 Aalborg University Hospital Aalborg Denmark 09000
    76 Odense University Hospital Odense Denmark 05000
    77 Sjaellands Universitetshospital Naestved Roskilde Denmark 04000
    78 Kuopio University Hospital Kuopio Finland 70210
    79 Oulu University Hospital Oulu Finland 90220
    80 Tampere University Hospital Tampere Finland 33520
    81 Turku University Hospital Turku Finland 20520
    82 Chu Amiens Picardie - Hopital Sud Amiens France 80054
    83 Chu Angers Hotel Dieu Nord Angers France 49933
    84 Groupe Bordeaux Nord Aquitaine Gbna Polycliniques - Polyclinique Bordeaux Nord Aquitaine Pbna Bordeaux France 33000
    85 Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand Dijon France 21000
    86 Centre Hospitalier de Versailles - Hopital Andre Mignot Le Chesnay France 78150
    87 CHU Nantes Nantes France 44093
    88 Hospital Saint-Louis Service Oncologie Medicale Paris France 75010
    89 A.P.H. Paris Hopital Cochin Paris France 75014
    90 Hôpital Pitié Salpêtrière Paris France 75651
    91 Centre Hospitalier de Pontoise Pontoise France 95303
    92 Centre Hospitalier Annecy-Genevois Pringy France 74374
    93 Chru Hopitaux de Tours Hospital Bretonneau Tours France 37044
    94 University Clinic Giessen Und Marburg Ukgm Giessen Germany 35392
    95 Universitaetsmedizin Greifswald Greifswald Germany 17475
    96 Universitaetsklinikum Wuerzburg Wuerzburg Germany 97080
    97 251 Air Force General Hospital Athens Greece 11525
    98 General Hospital of Athens Laiko Athens Greece 11527
    99 University Hospital of West Attica - Attikon Athens Greece 12462
    100 University General Hospital of Patras Patras Greece 26504
    101 Semmelweis Egyetem Budapest Hungary 01083
    102 National Institute of Oncology Budapest Hungary 01122
    103 Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika Debrecen Hungary 04032
    104 Markhot Ferenc Korhaz Eger Hungary 03300
    105 Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz Nyíregyháza Hungary 04400
    106 University of Szeged Szeged Hungary 06725
    107 Ha Emek Medical Center Afula Israel 18105
    108 Soroka Bear Sheva Israel
    109 Wolfson Holon Israel 5822012
    110 Shaare Zedek Mc Jerusalem Israel 9103102
    111 "Laiko" General Hospital of Athens, Hematology of the First Propaedeutic Internal Medicine Clinic Jerusalem Israel 91120
    112 Hadassah Jerusalem Israel 91120
    113 Rabin Medical Center - Beilinson Hospital Petah Tikva Israel 49100
    114 Sheba Medical Center Tel Hashomer Israel 5265601
    115 Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia Brescia Italy 25123
    116 Divisione Clinicizzata Di Ematologia Brescia Italy 25123
    117 Divisione Clinicizzata Di Ematologia Catania Italy 95123
    118 Presidio Ospedaliero Vito Fazzi Lecce Italy 73100
    119 Fondazione Irccs Istituto Nazionale Dei Tumori Milano Italy 20133
    120 Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milano Italy 20162
    121 Universita Di Napoli Federico Ii Napoli Italy 80131
    122 Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara Novara Italy 28100
    123 Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Palermo Italy 90146
    124 Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo Pavia Italy 27100
    125 Ausl Di Placenza Ospedale Guglielmo Da Saliceto Piacenza Italy 29100
    126 Ospedale Santa Maria Delle Croci Ravenna Italy 48121
    127 Arcispedale Santa Maria Nuova Reggio Emilia Italy 42100
    128 Ausl Della Romagna Rimini Italy 47923
    129 Ospedale Sant. Eugenio Rome Italy 00144
    130 Irccs Azienda Ospedaliera Universitaria San Martino San Martino Italy 16132
    131 National Hospital Organization Kyushu Cancer Center Fukuoka-shi Japan 811-1395
    132 Gifu Municipal Hospital Gifu-shi Japan 500-8513
    133 Kagoshima University Hospital Kagoshima-shi Japan 890-8520
    134 National Cancer Center Hospital East Kashiwa-shi Japan 277-8577
    135 Hospital of the University of Occupation and Environmental Health Kitakyushu-shi Japan 807-8556
    136 Kobe City Medical Center General Hospital Kobe-shi Japan 650-0047
    137 Japanese Red Cross Nagoya Daini Hospital Nagoya-shi Japan 466 8650
    138 Iuhw Narita Hospital Narita City Japan 286-8520
    139 Kindai University Hospital Osakasayama-shi Japan 589-8511
    140 Saitama Medical University Hospital Saitama Japan 350-0495
    141 Osaka University Hospital Suita-shi Japan 565-0871
    142 Juntendo University Hospital Tokyo Japan 113-8431
    143 Mie University Hospital Tsu-shi Japan 514-8507
    144 Yamagata University Hospital Yamagata-shi Japan 990-9585
    145 Pusan National University Yangsan Hospital Busan-si Korea, Republic of 03181
    146 Pusan National University Yangsan Hospital Busan-si Korea, Republic of 602-739
    147 Dong-A University Hospital Busan Korea, Republic of 49201
    148 Kyungpook National University Hospital Daegu Korea, Republic of 41944
    149 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 42601
    150 Gacheon University Gil Medical Center Incheon Korea, Republic of 21565
    151 Jeonbuk National University Hospital Jeonju Korea, Republic of 54907
    152 Seoul National University Hospital Seoul Korea, Republic of 03080
    153 Severance Hospital Yonsei University Health System Seoul Korea, Republic of 03722
    154 Samsung Medical Center Seoul Korea, Republic of 06351
    155 The Catholic Seoul Korea, Republic of 07345
    156 Amsterdam University Medical Centre Amsterdam Netherlands 1105 AZ
    157 Hospital Rijnstate Arnhem Netherlands 6815 AD
    158 Medisch Spectrum Twente Enschede Netherlands 7512 KZ
    159 Medisch Centrum Leeuwarden Leeuwarden Netherlands 8934 AD
    160 HMC Leidschendam Netherlands 2622BA
    161 Innlandet Hospital Trust Brumunddal Norway 02381
    162 Universitetssykehuset I Trondheim - St. Olavs Hospital Trondheim Norway 07006
    163 Szpital Spec Brzozowiepoland Brzozow Poland 36-200
    164 Pratia McM Krakow Krakow Poland 30-225
    165 Sp Zoz Szpital Uniwersytecki Krakow Poland 31-501
    166 Uniwersytet Medyczny W Lodzi - Klinika Hematologii Lodz Poland 93-510
    167 Specjalistyczny Szpital Onkologiczny Lodz Poland 97-200
    168 Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego Wroclaw Poland 50-367
    169 Hospital General Unviersitario de Alicante Alicante Spain 03010
    170 Ico Hospital Germans Trias I Pujol Badalona Spain 08916
    171 Hospital Del Mar Barcelona Spain 08003
    172 Hospital General Universitario Vall D Hebron Barcelona Spain 08007
    173 Hospital de La Santa Creu I Sant Pau Barcelona Spain 08041
    174 Hospital Universitario de Burgos Burgos Spain 09006
    175 Complejo Hospitalario Universitario A Coruna Coruna Spain 15006
    176 Hospital Universitario de Cabuenes Gijon Spain 33394
    177 Institut Catala Doncologia Ico - Hospital Duran I Reynals Location Hospitalet de Llobregat Spain 08908
    178 Hospital General Universitario Gregorio Maranon Madrid Spain 28007
    179 Hospital Universitario Ramon Y Cajal Madrid Spain 28034
    180 Fundacion Jimenez Diaz University Hospital Madrid Spain 28040
    181 Hospital Universitario 12 de Octubre Madrid Spain 28041
    182 Hospital Universitario Quironsalud Madrid Madrid Spain 28223
    183 Hospital Puerta de Hierro Majadahonda Spain 28222
    184 Hospital Universitario Virgen de La Victoria Malaga Spain 29010
    185 Hospital Universitario Virgen de La Arrixaca Murcia Spain 30120
    186 Hospital Son Llatzer Palma de Mallorca Spain 07198
    187 Consorci Hospitalari Parc Tauli de Sabadell Sabadell Spain 08208
    188 Hospital Universitario Marques de Valdecilla Santander Spain 39008
    189 Hospital Universitario Virgen del Rocio Sevilla Sevilla Spain 41005
    190 Hospital Universitari Mutua Terrassa Terrassa Spain 08221
    191 Hospital Universitario Doctor Peset Valencia Spain 46017
    192 Hospital Universitario de Alava Vitoria-gasteiz Spain 01009
    193 Goetalandsregionen - Uddevalla Sjukhus Us Uddevalla Sweden 451 53
    194 Uppsala Universitet - Akademiska Sjukhuset Uppsala Sweden 75185
    195 University Hospital of Basel Department of Oncology Basel Switzerland 04031
    196 Oncological Institute of Southern Switzerland Bellinzona Switzerland 06500
    197 Inselspital - Universitaetsspital Bern Bern Switzerland 03010
    198 Kantonsspital St. Gallen St. Gallen Switzerland 09007
    199 Kantonsspital Winterthur Winterthur Switzerland 08401
    200 E-Da Hospital Kaohsiung City Taiwan 00824
    201 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan 00833
    202 China Medical University Hospital Taichung Taiwan 40447
    203 National Cheng Kung University (Ncku) Hospital Tainan Taiwan 00704
    204 Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center Taipei City Taiwan 11251
    205 National Taiwan University Hospital Taipei Taiwan 00100
    206 Tri Service General Hospital Taipei Taiwan 00114
    207 Taipei Veterans General Hospital Taipei Taiwan 11217
    208 Hacettepe Universitesi Tip Fakultesi Hastanesi Ankara Turkey 06100
    209 Acibadem Maslak Hospital Istanbul Turkey 34457
    210 The Royal Marsden Nhs Foundation Trust - Chelsea London United Kingdom SW3 6JJ
    211 The Christie Nhs Foundation Trust Uk Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT04680052
    Other Study ID Numbers:
    • INCMOR 0208-301
    First Posted:
    Dec 22, 2020
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    MOR00208
    INCMOR00208
    tafasitamab
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular
    Lymphoma, B-Cell, Marginal Zone
    Rituximab
    Lenalidomide

    Study Results

    No Results Posted as of Aug 1, 2022