Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients (frontMIND)

February 29, 2024 updated by: MorphoSys AG

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

899

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • MorphoSys Research Site
      • Buenos Aires, Argentina, C1181ACH
        • MorphoSys Research Site
      • Cipolletti, Argentina, 8324
        • MorphoSys Research Site
      • Rosario, Argentina, 2000
        • MorphoSys Research Site
      • San Miguel de Tucuman, Argentina, T4000IVL
        • MorphoSys Research Site
  • Australia
      • Adelaide, Australia, 5000
        • MorphoSys Research Site
      • Ballarat, Australia, 3353
        • MorphoSys Research Site
      • Birtinya, Australia, 4575
        • MorphoSys Research Site
      • Brisbane, Australia, 4101
        • MorphoSys Research Site
      • Canberra, Australia, 2605
        • MorphoSys Research Site
      • Clayton, Australia, 3168
        • MorphoSys Research Site
      • Frankston, Australia, VIC 3199
        • MorphoSys Research Site
      • Geelong, Australia, 3220
        • MorphoSys Research Site
      • Gold Coast, Australia, QLD 4217
        • MorphoSys Research Site
      • Gosford, Australia, 2250
        • MorphoSys Research Site
      • Greenslopes, Australia, 4120
        • MorphoSys Research Site
      • Hobart, Australia, 7000
        • MorphoSys Research Site
      • Kingswood, Australia, 2747
        • MorphoSys Research Site
      • Kogarah, Australia, 2217
        • MorphoSys Research Site
      • Launceston, Australia, TAS 7250
        • MorphoSys Research Site
      • Malvern, Australia, 3144
        • MorphoSys Research Site
      • Melbourne, Australia, 3065
        • MorphoSys Research Site
      • Melbourne, Australia, 3084
        • MorphoSys Research Site
      • Nedlands, Australia, 6009
        • MorphoSys Research Site
      • Perth, Australia, 6000
        • MorphoSys Research Site
      • Perth, Australia, 6150
        • MorphoSys Research Site
      • Richmond, Australia, 3121
        • MorphoSys Research Site
      • St. Albans, Australia, 3021
        • MorphoSys Research Site
      • Sydney, Australia, 2050
        • MorphoSys Research Site
      • Sydney, Australia, 2145
        • MorphoSys Research Site
      • Townsville, Australia, 4817
        • MorphoSys Research Site
      • Wahroonga, Australia, 8833
        • MorphoSys Research Site
      • Waratah, Australia, 2298
        • MorphoSys Research Site
      • Wollongong, Australia, 2500
        • MorphoSys Research Site
  • Austria
      • Innsbruck, Austria, 6020
        • MorphoSys Research Site
      • Linz, Austria, 4010
        • MorphoSys Research Site
      • Linz, Austria, 4021
        • MorphoSys Research Site
      • Rankweil, Austria, 6830
        • MorphoSys Research Site
      • St. Poelten, Austria, 3100
        • MorphoSys Research Site
      • Vienna, Austria, 1090
        • MorphoSys Research Site
      • Vienna, Austria, 1140
        • MorphoSys Research Site
  • Canada
      • Halifax, Canada, B3H 2A7
        • MorphoSys Research Site
      • London, Canada, N6A 5W9
        • MorphoSys Research Site
      • Montreal, Canada, H3T 1E2
        • MorphoSys Research Site
      • Saskatoon, Canada, S7N 4H4
        • MorphoSys Research Site
      • Sherbrooke, Canada, J1G 2E8
        • MorphoSys Research Site
  • Colombia
      • Medellin, Colombia, 050034
        • MorphoSys Research Site
      • Valledupar, Colombia, 20001
        • MorphoSys Research Site
  • Czechia
      • Brno, Czechia, 625 00
        • MorphoSys Research Site
      • Hradec Králové, Czechia, 500 05
        • MorphoSys Research Site
      • Olomouc, Czechia, 775 20
        • MorphoSys Research Site
      • Ostrava, Czechia, 708 52
        • MorphoSys Research Site
      • Prague, Czechia, 100 34
        • MorphoSys Research Site
      • Prague, Czechia, 110 00
        • MorphoSys Research Site
      • Prague, Czechia, 150 06
        • MorphoSys Research Site
  • France
      • Amiens, France, 14033
        • MorphoSys Research Site
      • Bordeaux, France, 33074
        • MorphoSys Research Site
      • Bordeaux, France, 33076
        • MorphoSys Research Site
      • La Tronche, France, 38700
        • MorphoSys Research Site
      • Le Chesnay, France
        • MorphoSys Research Site
      • Le Mans, France, 72037
        • MorphoSys Research Site
      • Lille, France, 59020
        • MorphoSys Research Site
      • Limoges, France, 87042
        • MorphoSys Research Site
      • Marseille, France, 13385
        • MorphoSys Research Site
      • Nantes, France, 44093
        • MorphoSys Research Site
      • Poitiers, France, 86021
        • MorphoSys Research Site
      • Quimper, France, 29107
        • MorphoSys Research Site
      • Saint-Priest-en-Jarez, France, 42270
        • MorphoSys Research Site
      • Vandoeuvre-lès-Nancy, France
        • MorphoSys Research Site
      • Vannes, France, 56017
        • MorphoSys Research Site
    • Cedex 9
      • Caen, Cedex 9, France
        • MorphoSys Research Site
    • Pessac Cedax
      • Bordeau, Pessac Cedax, France
        • MorphoSys Research Site
  • Germany
      • Aachen, Germany, 52074
        • MorphoSys Research Site
      • Augsburg, Germany, 86156
        • MorphoSys Research Site
      • Berlin, Germany
        • MorphoSys Research Site
      • Berlin, Germany, 10967
        • MorphoSys Research Site
      • Berlin, Germany, 13353
        • MorphoSys Research Site
      • Bonn, Germany, 53127
        • MorphoSys Research Site
      • Chemnitz, Germany, 09116
        • MorphoSys Research Site
      • Cottbus, Germany, 03048
        • MorphoSys Research Site
      • Göttingen, Germany, 37075
        • MorphoSys Research Site
      • Halle, Germany, 06120
        • MorphoSys Research Site
      • Heilbronn, Germany, D-74078
        • MorphoSys Research Site
      • Jena, Germany, 07747
        • MorphoSys Research Site
      • Kassel, Germany, 34125
        • MorphoSys Research Site
      • Luebeck, Germany, 23538
        • MorphoSys Research Site
      • Magdeburg, Germany, 39120
        • MorphoSys Research Site
      • Mainz, Germany, 55131
        • MorphoSys Research Site
      • Marburg, Germany, 35043
        • MorphoSys Research Site
      • Muenster, Germany, 48149
        • MorphoSys Research Site
      • Munich, Germany, 81737
        • MorphoSys Research Site
      • Munich, Germany, 81675
        • MorphoSys Research Site
      • Paderborn, Germany, 33098
        • MorphoSys Research Site
      • Tuebingen, Germany, 65199
        • MorphoSys Research Site
      • Wiesbaden, Germany, 65191
        • MorphoSys Research Site
      • Wuerzburg, Germany, 97080
        • MorphoSys Research Site
      • Wuppertal, Germany, 42283
        • MorphoSys Research Site
  • Hungary
      • Budapest, Hungary, 1085
        • MorphoSys Research Site
      • Budapest, Hungary, H-1122
        • MorphoSys Research Site
      • Debrecen, Hungary, 4032
        • MorphoSys Research Site
      • Gyor, Hungary, 9024
        • MorphoSys Research Site
      • Nyíregyháza, Hungary
        • MorphoSys Research Site
      • Pécs, Hungary, H-7624
        • MorphoSys Research Site
  • Ireland
      • Dublin, Ireland
        • MorphoSys Research Site
      • Limerick, Ireland
        • MorphoSys Research Site
  • Israel
      • Be'er Sheva, Israel, 8410101
        • MorphoSys Research Site
      • Haifa, Israel, 31096
        • MorphoSys Research Site
      • Jerusalem, Israel, 9112001
        • MorphoSys Research Site
      • Petah-Tikva, Israel, 49100
        • MorphoSys Research Site
      • Ramat Gan, Israel
        • MorphoSys Research Site
      • Tel-Aviv, Israel, 6423906
        • MorphoSys Research Site
  • Italy
      • Bergamo, Italy, 24127
        • MorphoSys Research Site
      • Brescia, Italy, 25123
        • MorphoSys Research Site
      • Candiolo, Italy, 10060
        • MorphoSys Research Site
      • Catania, Italy, 95123
        • MorphoSys Research Site
      • Forli, Italy, 47014
        • MorphoSys Research Site
      • Genoa, Italy, 16132
        • MorphoSys Research Site
      • Lecce, Italy, 73100
        • MorphoSys Research Site
      • Milan, Italy, 20141
        • MorphoSys Research Site
      • Novara, Italy, 28100
        • MorphoSys Research Site
      • Orbassano, Italy, 10043
        • MorphoSys Research Site
      • Padova, Italy, 35128
        • MorphoSys Research Site
      • Palermo, Italy, 90146
        • MorphoSys Research Site
      • Pavia, Italy, 27100
        • MorphoSys Research Site
      • Ravenna, Italy, 48121
        • MorphoSys Research Site
      • Rimini, Italy, 47923
        • MorphoSys Research Site
      • Rozzano, Italy, 20089
        • MorphoSys Research Site
      • Siena, Italy, 15121
        • MorphoSys Research Site
      • Siena, Italy, 53100
        • MorphoSys Research Site
      • Terni, Italy, 05100
        • MorphoSys Research Site
      • Tricase, Italy, 73039
        • MorphoSys Research Site
      • Trieste, Italy, 34129
        • MorphoSys Research Site
      • Turin, Italy, 10126
        • MorphoSys Research Site
  • Japan
      • Fukuoka, Japan, 810-8563
        • MorphoSys Research Site
      • Gifu, Japan, 500-8513
        • MorphoSys Research Site
      • Ibaraki, Japan, 311-3193
        • MorphoSys Research Site
      • Isehara, Japan, 259-1193
        • MorphoSys Research Site
      • Kagoshima, Japan, 890-8520
        • MorphoSys Research Site
      • Nagoya, Japan, 466-8650
        • MorphoSys Research Site
      • Narita-shi, Japan, 286-8520
        • MorphoSys Research Site
      • Okayama, Japan, 701-1192
        • MorphoSys Research Site
      • Osaka, Japan, 565-0871
        • MorphoSys Research Site
      • Osakasayama-shi, Japan, 589-8511
        • MorphoSys Research Site
      • Sapporo, Japan, 003-0804
        • MorphoSys Research Site
      • Tachikawa, Japan, 190-0014
        • MorphoSys Research Site
      • Tokyo, Japan, 113-8603
        • MorphoSys Research Site
      • Tokyo, Japan, 142-8666
        • MorphoSys Research Site
      • Tokyo, Japan, 162-8666
        • MorphoSys Research Site
      • Tsu-shi, Japan, 514-8507
        • MorphoSys Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • MorphoSys Research Site
      • Busan, Korea, Republic of, 47392
        • MorphoSys Research Site
      • Busan, Korea, Republic of, 4924
        • MorphoSys Research Site
      • Busan, Korea, Republic of, 49267
        • MorphoSys Research Site
      • Daegu, Korea, Republic of, 42415
        • MorphoSys Research Site
      • Daegu, Korea, Republic of, 42472
        • MorphoSys Research Site
      • Daegu, Korea, Republic of, 42601
        • MorphoSys Research Site
      • Goyang-si, Korea, Republic of, 10408
        • MorphoSys Research Site
      • Incheon, Korea, Republic of
        • MorphoSys Research Site
      • Jeonju, Korea, Republic of, 561-712
        • MorphoSys Research Site
      • Jinju-si, Korea, Republic of
        • MorphoSys Research Site
      • Seoul, Korea, Republic of, 05505
        • MorphoSys Research Site
      • Seoul, Korea, Republic of, 07985
        • MorphoSys Research Site
      • Seoul, Korea, Republic of, 03080
        • MorphoSys Research Site
      • Seoul, Korea, Republic of, 03181
        • MorphoSys Research Site
      • Seoul, Korea, Republic of, 037222
        • MorphoSys Research Site
      • Seoul, Korea, Republic of, 07345
        • MorphoSys Research Site
      • Yangsan, Korea, Republic of, 50612
        • MorphoSys Research Site
  • Malaysia
      • Alor Setar, Malaysia, 05460
        • MorphoSys Research Site
      • Ampang, Malaysia, 68000
        • MorphoSys Research Site
      • George Town, Malaysia, 10990
        • MorphoSys Research Site
      • Ipoh, Malaysia, 30450
        • MorphoSys Research Site
      • Johor Bahru, Malaysia, 80100
        • MorphoSys Research Site
      • Kota Bharu, Malaysia, 16150
        • MorphoSys Research Site
      • Kuala Lumpur, Malaysia, 59100
        • MorphoSys Research Site
      • Kuantan, Malaysia, 25100
        • MorphoSys Research Site
      • Kuching, Malaysia, 93586
        • MorphoSys Research Site
      • Petaling Jaya, Malaysia, 47500
        • MorphoSys Research Site
      • Subang Jaya, Malaysia, 47500
        • MorphoSys Research Site
  • New Zealand
      • Auckland, New Zealand, 1023
        • MorphoSys Research Site
  • Philippines
      • Manila, Philippines, 1000
        • MorphoSys Research Site
      • Pasig City, Philippines, 1605
        • MorphoSys Research Site
      • Quezon City, Philippines, 1112
        • MorphoSys Research Site
  • Poland
      • Warsaw, Poland, 02-781
        • MorphoSys Research Site
      • Łódź, Poland
        • MorphoSys Research Site
  • Romania
      • Brasov, Romania, 500366
        • MorphoSys Research Site
      • Bucharest, Romania, 050098
        • MorphoSys Research Site
      • Bucharest, Romania
        • MorphoSys Research Site
      • Cluj-Napoca, Romania
        • MorphoSys Research Site
      • Craiova, Romania
        • MorphoSys Research Site
      • Iasi, Romania, 700483
        • MorphoSys Research Site
  • Russian Federation
      • Kazan, Russian Federation, 420029
        • MorphoSys Research Site
      • Moscow, Russian Federation
        • MorphoSys Research Site
      • Novosibirsk, Russian Federation, 630087
        • MorphoSys Research Site
      • Petrozavodsk, Russian Federation
        • MorphoSys Research Site
      • Saint Petersburg, Russian Federation, 197341
        • MorphoSys Research Site
      • Saint Petersburg, Russian Federation, 197758
        • MorphoSys Research Site
      • Saint Petersburg, Russian Federation
        • MorphoSys Research Site
      • UFA, Russian Federation
        • MorphoSys Research Site
  • Serbia
      • Belgrade, Serbia, 11 000
        • MorphoSys Research Site
      • Belgrade, Serbia, 11 080
        • MorphoSys Research Site
      • Novi Sad, Serbia
        • MorphoSys Research Site
      • Sremska Kamenica, Serbia, 21204
        • MorphoSys Research Site
  • Slovakia
      • Bratislava, Slovakia, 83310
        • MorphoSys Research Site
      • Košice, Slovakia, 04166
        • MorphoSys Research Site
  • Spain
      • Badalona, Spain, 08916
        • MorphoSys Research Site
      • Barcelona, Spain, 08035
        • MorphoSys Research Site
      • Barcelona, Spain, 08908
        • MorphoSys Research Site
      • Girona, Spain, 17007
        • MorphoSys Research Site
      • Jerez de la Frontera, Spain, 11407
        • MorphoSys Research Site
      • Lugo, Spain, 27003
        • MorphoSys Research Site
      • Madrid, Spain, 28040
        • MorphoSys Research Site
      • Madrid, Spain, 28223
        • MorphoSys Research Site
      • Madrid, Spain, 28050
        • MorphoSys Research Site
      • Madrid, Spain, 28041
        • MorphoSys Research Site
      • Madrid, Spain, 28034
        • MorphoSys Research Site
      • Pamplona, Spain, 31008
        • MorphoSys Research Site
      • Salamanca, Spain, 37007
        • MorphoSys Research Site
      • Seville, Spain, 41009
        • MorphoSys Research Site
      • Seville, Spain, 41013
        • MorphoSys Research Site
      • Seville, Spain, 41014
        • MorphoSys Research Site
      • Valencia, Spain, 46017
        • MorphoSys Research Site
      • Vitoria-Gasteiz, Spain, 01009
        • MorphoSys Research Site
  • Taiwan
      • Chang Hua, Taiwan
        • MorphoSys Research Site
      • Chiayi City, Taiwan, 613
        • MorphoSys Research Site
      • Hualien City, Taiwan
        • MorphoSys Research Site
      • Kaohsiung, Taiwan, 833401
        • MorphoSys Research Site
      • Kaohsiung, Taiwan
        • MorphoSys Research Site
      • New Taipei City, Taiwan
        • MorphoSys Research Site
      • Taichung, Taiwan, 40705
        • MorphoSys Research Site
      • Taichung, Taiwan, 40447
        • MorphoSys Research Site
      • Tainan, Taiwan, 71004
        • MorphoSys Research Site
      • Taipei, Taiwan, 100226
        • MorphoSys Research Site
      • Taoyuan, Taiwan
        • Morphsys Research Site
  • Thailand
      • Bangkok, Thailand, 10400
        • MorphoSys Research Site
      • Bangkok, Thailand, 10500
        • MorphoSys Research Site
      • Chiang Mai, Thailand, 50200
        • MorphoSys Research Site
      • Khon Kaen, Thailand, 40000
        • MorphoSys Research Site
      • Pathum Thani, Thailand, 12120
        • MorphoSys Research Site
  • Turkey
      • Ankara, Turkey, 06590
        • MorphoSys Research Site
      • Ankara, Turkey
        • MorphoSys Research Site
      • Izmir, Turkey, 35100
        • MorphoSys Research Site
      • Malatya, Turkey, 44280
        • MorphoSys Research Site
      • Mersin, Turkey, 33343
        • MorphoSys Research Site
      • İzmit, Turkey, 41380
        • MorphoSys Research Site
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • MorphoSys Research Site
      • Chernihiv, Ukraine, 14029
        • MorphoSys Research Site
      • Kharkiv, Ukraine, 61070
        • MorphoSys Research Site
      • Kyiv, Ukraine, 03022
        • MorphoSys Research Site
      • Kyiv, Ukraine, 03115
        • MorphoSys Research Site
      • Kyiv, Ukraine, 03680
        • MorphoSys Research Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • MorphoSys Research Site
      • Bath, United Kingdom, BA1 3NG
        • MorphoSys Research Site
      • Birmingham, United Kingdom, B15 2TH
        • MorphoSys Research Site
      • Bristol, United Kingdom, BS2 8ED
        • MorphoSys Research Site
      • London, United Kingdom, EC1M 6BQ
        • MorphoSys Research Site
      • London, United Kingdom, SM2 5PT
        • MorphoSys Research Site
      • London, United Kingdom, SW3 6JJ
        • MorphoSys Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • MorphoSys Research Site
      • Sutton, United Kingdom, SW17 0QT
        • MorphoSys Research Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • MorphoSys Research Site
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • MorphoSys Research Site
    • California
      • Anaheim, California, United States, 92801
        • MorphoSys Research Site
      • Clovis, California, United States, 93611
        • MorphoSys Research Site
      • Fullerton, California, United States, 92834-4138
        • MorphoSys Research Site
      • Harbor City, California, United States, 90710
        • MorphoSys Research Site
      • Los Angeles, California, United States, 90017
        • MorphoSys Research Site
      • San Diego, California, United States, 92123
        • MorphoSys Research Site
      • Whittier, California, United States, 90603
        • MorphoSys Research Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • MorphoSys Research Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • MorphoSys Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • MorphoSys Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • MorphoSys Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • MorphoSys Research Site
      • Louisville, Kentucky, United States, 40241
        • MorphoSys Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • MorphoSys Research Site
      • Bethesda, Maryland, United States, 20817-7847
        • MorphoSys Research Site
      • Columbia, Maryland, United States, 21044
        • MorphoSys Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • MorphoSys Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55426
        • MorphoSys Research Site
      • Rochester, Minnesota, United States, 55905
        • MorphoSys Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • MorphoSys Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03755
        • MorphoSys Research Site
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • MorphoSys Research Site
    • New York
      • Buffalo, New York, United States, 14263
        • MorphoSys Research Site
      • Rochester, New York, United States, 14642
        • MorphoSys Research Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • MorphoSys Research Site
      • Cincinnati, Ohio, United States, 45242
        • MorphoSys Research Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • MorphoSys Research Site
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-4910
        • MorphoSys Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • MorphoSys Research Site
      • Germantown, Tennessee, United States, 38138
        • MorphoSys Research Site
      • Nashville, Tennessee, United States, 37203
        • MorphoSys Research Site
    • Texas
      • Austin, Texas, United States, 78745
        • MorphoSys Research Site
      • Bedford, Texas, United States, 76022
        • MorphoSys Research Site
      • Denison, Texas, United States, 75020
        • MorphoSys Research Site
      • Fort Worth, Texas, United States, 76104
        • MorphoSys Research Site
      • Houston, Texas, United States, 77030
        • MorphoSys Research Site
      • McAllen, Texas, United States, 78503
        • MorphoSys Research Site
      • Tyler, Texas, United States, 75702
        • MorphoSys Research Site
    • Utah
      • Ogden, Utah, United States, 84405
        • MorphoSys Research Site
      • Salt Lake City, Utah, United States, 84112
        • MorphoSys Research Site
    • Virginia
      • Gainesville, Virginia, United States, 20155
        • MorphoSys Research Site
      • Roanoke, Virginia, United States, 24014
        • MorphoSys Research Site
      • Virginia Beach, Virginia, United States, 23456
        • MorphoSys Research Site
    • Washington
      • Olympia, Washington, United States, 98502
        • MorphoSys Research Site
      • Tacoma, Washington, United States, 98405
        • MorphoSys Research Site
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • MorphoSys Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Major Inclusion Criteria:

  • Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms are eligible:

    1. DLBCL, NOS including GCB type, ABC type
    2. T-cell rich large BCL
    3. Epstein-Barr virus-positive DLBCL, NOS
    4. Anaplastic lymphoma kinase (ALK)-positive large BCL
    5. Human herpes virus-8 (HHV8)-positive DLBCL, NOS
    6. High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma). Please note: Patients must be appropriate candidates for R-CHOP. If an investigator deems a patient with a known double- or triple-hit lymphoma (HGBL) should be treated more aggressively (e.g. dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab [DA-EPOCH-R] or cyclophosphamide, vincristine, doxorubicin and dexamethasone (CVAD) followed by methotrexate and cytarabine [Hyper CVAD]), this patient would not be considered eligible for this study
    7. HGBL-NOS
    8. DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma
    9. FL grade 3b
  • Availability of archival or freshly collected tumor tissue sent for retrospective central pathology review
  • IPI status of 3 to 5 (for patients > 60 years of age) or aaIPI 2 to 3 (for patients ≤ 60 years of age)
  • Diagnosis to treatment interval, defined as the time between the date of DLBCL diagnosis (date of the first biopsy specimen containing B Cell lymphoma according to the local pathology report) and the start of treatment (C1D1) ≤ 28 days
  • ECOG performance status of 0, 1, or 2
  • Left ventricular ejection fraction equal to or greater 50% as assessed by local echocardiography or cardiac multi-gated acquisition (MUGA) scan
  • Adequate hematologic function
  • Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from breast feeding and donating eggs; agreement to ongoing pregnancy testing during the course of the study, and after study therapy has ended
  • Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm

Major Exclusion Criteria:

  • Any other histological type of lymphoma according to WHO 2016 classification of lymphoid neoplasms, e.g., primary mediastinal (thymic) large B-cell lymphoma, Burkitt's lymphoma, BCL, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; primary DLBCL of the CNS; DLBCL arising from CLL or indolent lymphoma

  • History of prior non-hematologic malignancy except for the following:

    1. Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening
    2. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer
    3. Adequately treated carcinoma in situ without current evidence of disease
  • Any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment
  • Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines
  • Known CNS lymphoma involvement
  • Known active systemic bacterial, viral, fungal, or other infection at screening, including patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
  • History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tafasitamab plus lenalidomide in addition to R-CHOP

Patients will receive tafasitamab plus lenalidomide in addition to R-CHOP for six 21-day cycles:

Tafasitamab dose: 12 mg/kg body weight. Each 21-day cycle (cycles 1-6) will comprise of a tafasitamab IV infusion on Day 1, Day 8 and Day 15.

Lenalidomide dose: 25 mg as a starting dose per os (orally) once per day on Days 1-10 of each 21-day cycle

R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle
Drug: Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Drug: Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Tafasitamab
Tafasitamab IV infusion will be administered as per the schedule specified in the respective arm.
Other Names:
  • Monjuvi
Drug: Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Placebo Comparator: Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP

Patients will receive tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP for six 21-day cycles:

Tafasitamab placebo: 0.9% saline solution Days 1, 8 and 15 of each 21-day cycle

Lenalidomide placebo: Days 1-10 of each 21-day cycle

R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle
Drug: Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Drug: Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Tafasitamab placebo
0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm.
Drug: Lenalidomide placebo
Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS-INV
Time Frame: Time from date of randomization until Progressive Disease or death from any cause. In this trial, the primary endpoint is PFS as assessed by the investigator (up to 43 months)
Progression-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma
Time from date of randomization until Progressive Disease or death from any cause. In this trial, the primary endpoint is PFS as assessed by the investigator (up to 43 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFS-INV
Time Frame: From randomization until the first occurrence of disease progression or relapse as assessed by the INV using, start of new anti-lymphoma treatment or death from any cause, whichever occurs first (up to 43 months)
Event-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma
From randomization until the first occurrence of disease progression or relapse as assessed by the INV using, start of new anti-lymphoma treatment or death from any cause, whichever occurs first (up to 43 months)
OS
Time Frame: From randomization until the date of death from any cause (up to 62 months)
Overall Survival
From randomization until the date of death from any cause (up to 62 months)
Metabolic PET-negative CR-rate at EOT by BIRC
Time Frame: End of treatment, 4-8 weeks after last dose
Metabolic PET-negative CR rate defined as the proportion of patients who achieved metabolic PET-negative CR as per Lugano 2014 criteria based on PET/CTs performed at the end of the treatment by BIRC
End of treatment, 4-8 weeks after last dose
Metabolic PET-negative CR-rate at EOT by INV
Time Frame: End of treatment, 4-8 weeks after last dose
Metabolic PET-negative CR rate defined as the proportion of patients who achieved metabolic PET-negative CR as per Lugano 2014 criteria based on PET/CTs performed at the end of the treatment by the investigator
End of treatment, 4-8 weeks after last dose
PFS at 3 years
Time Frame: 36 months after randomization
Progression-Free Survival as assessed by the investigator
36 months after randomization
EFS at 3 years
Time Frame: 36 months after randomization
Event-Free Survival as assessed by the investigator
36 months after randomization
OS at 3 years
Time Frame: 36 months after randomization
Overall Survival
36 months after randomization
ORR as per INV at EOT
Time Frame: 6 ± 2 weeks after End of Treatment
Overall response rate defined as the proportion of patients with CR or PR as per Lugano 2014 criteria based on assessment at the end of the treatment by the INV
6 ± 2 weeks after End of Treatment
Time to next anti-lymphoma treatment (TTNT)
Time Frame: From randomization date to start of next anti-lymphoma therapy (for any reason including disease progression, treatment toxicity, and patient preference) or death due to any cause, whatever comes first (up to 43 months)
TTNT is defined as the time from randomization date to start of next anti-lymphoma therapy (for any reason including disease progression, treatment toxicity, and patient preference) or death due to any cause, whatever comes first.
From randomization date to start of next anti-lymphoma therapy (for any reason including disease progression, treatment toxicity, and patient preference) or death due to any cause, whatever comes first (up to 43 months)
Duration of Complete Response (CR) as assessed by the investigator
Time Frame: From the date of the first occurrence of a documented CR, to the date of progression, relapse, or death from any cause, whichever is earlier (up to 43 months)
Duration of CR is defined as the time from the date of the first occurrence of a documented CR, to the date of progression, relapse, or death from any cause, whichever is earlier for the subgroup of patients with a Best Overall Response (BOR) of CR.
From the date of the first occurrence of a documented CR, to the date of progression, relapse, or death from any cause, whichever is earlier (up to 43 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MorphoSys AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2021

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOR208C310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diffuse Large B-cell Lymphoma

Clinical Trials on Rituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe