Diffuse Large B-cell LymphomaPhase 3frontMINDNCT04824092
Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients
A Phase 3 study testing Tafasitamab, Lenalidomide and Rituximab in people with Diffuse Large B-cell Lymphoma, run by Incyte Corporation at 307 sites in 29 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Tafasitamab, Lenalidomide and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 899 participants
- Where
- 307 sitesin 29 countries
- Study dates
- 11 May 2021to 1 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
- DLBCL, NOS including GCB type, ABC type
- T-cell rich large BCL
- Epstein-Barr virus-positive DLBCL, NOS
- Anaplastic lymphoma kinase (ALK)-positive large BCL
- Human herpes virus-8 (HHV8)-positive DLBCL, NOS
- 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
- HGBL-NOS
- DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma
- 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:
- Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening
- Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer
- 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
Trial locations and contacts
307 sites in 29 countries.
307 sites in 29 countries
United States47 sites
MorphoSys Research Site
Anaheim, California, 92801
MorphoSys Research Site
Aurora, Colorado, 80012
MorphoSys Research Site
Austin, Texas, 78745
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Baltimore, Maryland, 21237
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Bedford, Texas, 76022
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Bethesda, Maryland, 20817-7847
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Buffalo, New York, 14263
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Canton, Ohio, 44718
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Chattanooga, Tennessee, 37404
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Cincinnati, Ohio, 45242
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Clovis, California, 93611
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Columbia, Maryland, 21044
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Danville, Pennsylvania, 17822-4910
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Daphne, Alabama, 36526
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Denison, Texas, 75020
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Detroit, Michigan, 48202
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Eugene, Oregon, 97401
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Florham Park, New Jersey, 07932
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Fort Worth, Texas, 76104
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Fullerton, California, 92834-4138
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Gainesville, Virginia, 20155
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Germantown, Tennessee, 38138
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Harbor City, California, 90710
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Honolulu, Hawaii, 96813
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Houston, Texas, 77030
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Jacksonville, Florida, 32224
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Kansas City, Missouri, 64132
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Lebanon, New Hampshire, 03755
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Lexington, Kentucky, 40536-0293
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Los Angeles, California, 90017
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Louisville, Kentucky, 40241
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Marshfield, Wisconsin, 54449
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McAllen, Texas, 78503
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Minneapolis, Minnesota, 55426
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Nashville, Tennessee, 37203
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Ogden, Utah, 84405
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Olympia, Washington, 98502
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Roanoke, Virginia, 24014
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Rochester, Minnesota, 55905
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Rochester, New York, 14642
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Salt Lake City, Utah, 84112
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San Diego, California, 92123
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Tacoma, Washington, 98405
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Tyler, Texas, 75702
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Virginia Beach, Virginia, 23456
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Whittier, California, 90603
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Wichita, Kansas, 67214
Australia29 sites
MorphoSys Research Site
Adelaide, 5000
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Ballarat, 3353
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Birtinya, 4575
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Brisbane, 4101
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Canberra, 2605
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Clayton, 3168
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Frankston, VIC 3199
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Geelong, 3220
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Gold Coast, QLD 4217
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Gosford, 2250
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Greenslopes, 4120
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Hobart, 7000
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Kingswood, 2747
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Kogarah, 2217
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Launceston, TAS 7250
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Malvern, 3144
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Melbourne, 3065
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Melbourne, 3084
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Nedlands, 6009
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Perth, 6000
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Perth, 6150
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Richmond, 3121
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St Albans, 3021
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Sydney, 2050
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Sydney, 2145
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Townsville, 4817
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Wahroonga, 8833
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Waratah, 2298
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Wollongong, 2500
Germany25 sites
MorphoSys Research Site
Aachen, 52074
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Augsburg, 86156
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Berlin, 10967
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Berlin, 13353
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Berlin
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Bonn, 53127
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Chemnitz, 09116
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Cottbus, 03048
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Göttingen, 37075
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Halle, 06120
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Heilbronn, D-74078
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Jena, 07747
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Kassel, 34125
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Lübeck, 23538
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Magdeburg, 39120
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Mainz, 55131
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Marburg, 35043
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Munich, 81675
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Munich, 81737
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Münster, 48149
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Paderborn, 33098
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Tübingen, 65199
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Wiesbaden, 65191
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Wuppertal, 42283
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Würzburg, 97080
Italy22 sites
MorphoSys Research Site
Bergamo, 24127
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Brescia, 25123
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Candiolo, 10060
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Catania, 95123
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Forlì, 47014
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Genoa, 16132
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Lecce, 73100
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Milan, 20141
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Novara, 28100
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Orbassano, 10043
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Padova, 35128
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Palermo, 90146
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Pavia, 27100
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Ravenna, 48121
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Rimini, 47923
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Rozzano, 20089
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Siena, 15121
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Siena, 53100
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Terni, 05100
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Tricase, 73039
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Trieste, 34129
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Turin, 10126
South Korea18 sites
MorphoSys Research Site
Busan, 47392
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Busan, 49201
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Busan, 4924
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Busan, 49267
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Daegu, 42415
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Daegu, 42472
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Daegu, 42601
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Goyang-si, 10408
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Incheon
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Jeonju, 561-712
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Jinju
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Seoul, 03080
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Seoul, 03181
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Seoul, 037222
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Seoul, 05505
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Seoul, 07345
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Seoul, 07985
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Yangsan, 50612
Spain18 sites
MorphoSys Research Site
Badalona, 08916
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Barcelona, 08035
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Barcelona, 08908
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Girona, 17007
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Jerez de la Frontera, 11407
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Lugo, 27003
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Madrid, 28034
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Madrid, 28040
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Madrid, 28041
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Madrid, 28050
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Madrid, 28223
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Pamplona, 31008
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Salamanca, 37007
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Seville, 41009
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Seville, 41013
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Seville, 41014
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Valencia, 46017
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Vitoria-Gasteiz, 01009
France17 sites
MorphoSys Research Site
Amiens, 14033
Morphosys Research Site
Bordeau, Pessac Cedax
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Bordeaux, 33074
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Bordeaux, 33076
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Caen, Cedex 9
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La Tronche, 38700
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Le Chesnay
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Le Mans, 72037
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Lille, 59020
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Limoges, 87042
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Marseille, 13385
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Nantes, 44093
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Poitiers, 86021
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Quimper, 29107
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Saint-Priest-en-Jarez, 42270
MorphoSys Research Site
Vandœuvre-lès-Nancy
MorphoSys Research Site
Vannes, 56017
Japan16 sites
MorphoSys Research Site
Fukuoka, 810-8563
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Gifu, 500-8513
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Ibaraki, 311-3193
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Isehara, 259-1193
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Kagoshima, 890-8520
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Nagoya, 466-8650
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Narita-shi, 286-8520
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Okayama, 701-1192
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Osaka, 565-0871
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Osakasayama-shi, 589-8511
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Sapporo, 003-0804
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Tachikawa, 190-0014
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Tokyo, 113-8603
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Tokyo, 142-8666
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Tokyo, 162-8666
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Tsu, 514-8507
Malaysia11 sites
MorphoSys Research Site
Alor Star, 05460
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Ampang, 68000
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George Town, 10990
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Ipoh, 30450
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Johor Bahru, 80100
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Kota Bharu, 16150
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Kuala Lumpur, 59100
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Kuantan, 25100
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Kuching, 93586
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Petaling Jaya, 47500
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Subang Jaya, 47500
Taiwan11 sites
Morphosys Research Site
Chang-hua
Morphosys Research Site
Chiayi City, 613
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Hualien City
MorphoSys Research Site
Kaohsiung City, 833401
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Kaohsiung City
Morphosys Research Site
New Taipei City
Morphosys Research Site
Taichung, 40447
MorphoSys Research Site
Taichung, 40705
MorphoSys Research Site
Tainan, 71004
MorphoSys Research Site
Taipei, 100226
Morphsys Research Site
Taoyuan
United Kingdom10 sites
MorphoSys Research Site
Aberdeen, AB25 2ZN
MorphoSys Research Site
Bath, BA1 3NG
MorphoSys Research Site
Birmingham, B15 2TH
MorphoSys Research Site
Bristol, BS2 8ED
MorphoSys Research Site
London, EC1M 6BQ
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London, SM2 5PT
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London, SW3 6JJ
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Nottingham, NG5 1PB
MorphoSys Research Site
Sutton, SW17 0QT
MorphoSys Research Site
Wolverhampton, WV10 0QP
Russia8 sites
MorphoSys Research Site
Kazan', 420029
Morphosys Research Site
Moscow
MorphoSys Research Site
Novosibirsk, 630087
Morphosys Research Site
Petrozavodsk
MorphoSys Research Site
Saint Petersburg, 197341
MorphoSys Research Site
Saint Petersburg, 197758
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Saint Petersburg
Morphosys research site
Ufa
Austria7 sites
MorphoSys Research Site
Innsbruck, 6020
MorphoSys Research Site
Linz, 4010
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Linz, 4021
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Rankweil, 6830
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Sankt Pölten, 3100
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Vienna, 1090
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Vienna, 1140
Czechia7 sites
MorphoSys Research Site
Brno, 625 00
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Hradec Králové, 500 05
MorphoSys Research Site
Olomouc, 775 20
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Ostrava, 708 52
MorphoSys Research Site
Prague, 100 34
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Prague, 110 00
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Prague, 150 06
Hungary6 sites
MorphoSys Research Site
Budapest, 1085
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Budapest, H-1122
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Debrecen, 4032
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Győr, 9024
Morphosys Research Site
Nyíregyháza
MorphoSys Research Site
Pécs, H-7624
Israel6 sites
MorphoSys Research Site
Beersheba, 8410101
MorphoSys Research Site
Haifa, 31096
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Jerusalem, 9112001
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Petah Tikva, 49100
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Ramat Gan
MorphoSys Research Site
Tel Aviv, 6423906
Romania6 sites
MorphoSys Research Site
Brasov, 500366
MorphoSys Research Site
Bucharest, 050098
Morphosys Research Site
Bucharest
Morphosys Research Site
Cluj-Napoca
Morphosys Research Site
Craiova
MorphoSys Research Site
Iași, 700483
Turkey (Türkiye)6 sites
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Ankara, 06590
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Ankara
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Izmir, 35100
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İzmit, 41380
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Malatya, 44280
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Mersin, 33343
Ukraine6 sites
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Cherkasy, 18009
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Chernihiv, 14029
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Kharkiv, 61070
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Kyiv, 03022
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Kyiv, 03115
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Kyiv, 03680
Argentina5 sites
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Buenos Aires, C1118AAT
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Buenos Aires, C1181ACH
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Cipolletti, 8324
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Rosario, 2000
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San Miguel de Tucumán, T4000IVL
Canada5 sites
MorphoSys Research Site
Halifax, B3H 2A7
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London, N6A 5W9
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Montreal, H3T 1E2
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Saskatoon, S7N 4H4
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Sherbrooke, J1G 2E8
Thailand5 sites
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Bangkok, 10400
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Bangkok, 10500
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Chiang Mai, 50200
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Khon Kaen, 40000
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Pathum Thani, 12120
Serbia4 sites
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Belgrade, 11 000
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Belgrade, 11 080
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Kamenitz, 21204
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Novi Sad
Philippines3 sites
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Manila, 1000
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Pasig, 1605
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Quezon City, 1112
Colombia2 sites
MorphoSys Research Site
Medellín, 050034
MorphoSys Research Site
Valledupar, 20001
Poland2 sites
Morphosys Research Site
Lodz
MorphoSys Research Site
Warsaw, 02-781
Slovakia2 sites
MorphoSys Research Site
Bratislava, 83310
MorphoSys Research Site
Košice, 04166
About this study
Official title: 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
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Tafasitamab, Lenalidomide, Rituximab, Cyclophosphamide, Doxorubicin
- Keywords
- DLBCL, CD19, monoclonal antibody, tafasitamab, lenalidomide, R-CHOP, Diffuse Large B-cell Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafasitamabDrug
Also called Monjuvi
Tafasitamab IV infusion will be administered as per the schedule specified in the respective arm.
LenalidomideDrug
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
RituximabDrug
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
CyclophosphamideDrug
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DoxorubicinDrug
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
VincristineDrug
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
PrednisoneDrug
Prednisone PO will be administered as per the schedule specified in the respective arm.
Tafasitamab placeboDrug
0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm.
Lenalidomide placeboDrug
Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| Tafasitamab plus lenalidomide in addition to R-CHOP | Experimental | 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 Receives: Drug: Tafasitamab; Drug: Lenalidomide; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
| Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP | Placebo comparator | 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 Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Tafasitamab placebo; Drug: Lenalidomide placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS-INV
Progression-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma
Measured: 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 outcomes (10)
EFS-INV
Event-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma
Measured: 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
Overall Survival
Measured: From randomization until the date of death from any cause (up to 62 months)
Metabolic PET-negative CR-rate at EOT by BIRC
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
Measured: End of treatment, 4-8 weeks after last dose
Metabolic PET-negative CR-rate at EOT by INV
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
Measured: End of treatment, 4-8 weeks after last dose
ORR as per INV at EOT
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
Measured: 6 ± 2 weeks after End of Treatment
Time to next anti-lymphoma treatment (TTNT)
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.
Measured: 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
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.
Measured: 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)
EFS at 3 years
Event-Free Survival as assessed by the investigator
Measured: 36 months after randomization
PFS at 3 years
Progression-Free Survival as assessed by the investigator
Measured: 36 months after randomization
OS at 3 years
Overall Survival
Measured: 36 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start11 May 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 899 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Director, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824092
- Sponsor's protocol ID
- MOR208C310
- Other IDs
- 2022-500237-92-00, 2020-002990-84
- Acronym
- frontMIND
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2021
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lenz G, Trneny M, Burke JM, Nowakowski GS, Fox CP, Chiappella A, Duell J, Jeon YW, Cheah CY, Westin J, Ye JZ, Caguioa PB, Belada D, Shin HJ, Oh SY, Amorim S, Ku M, Mocikova H, Jimenez JL, Gaidano G, Rosenwald A, Chiarle R, Colucci P, Ioannidis S, Cheng L, Vitolo U; frontMIND Study Investigators. Tafasitamab plus lenalidomide and R-CHOP versus R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma (frontMIND): a global, phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2026 Jun 20;407(10547):2528-2541. doi: 10.1016/S0140-6736(26)00866-4. Epub 2026 May 30.
PubMed 42217458Jelicic J, Juul-Jensen K, Bukumiric Z, Runason Simonsen M, Roost Clausen M, Ludvigsen Al-Mashhadi A, Schou Pedersen R, Poulsen CB, Gang AO, Brown P, El-Galaly TC, Stauffer Larsen T. International Prognostic Models as Tools for Selection of Higher-risk Trial-eligible Patients With Diffuse Large B-Cell lymphoma. Clin Lymphoma Myeloma Leuk. 2026 Jan;26(1):e62-e76. doi: 10.1016/j.clml.2025.08.020. Epub 2025 Sep 3.
PubMed 40993016Duell J, Westin J. The future of immunotherapy for diffuse large B-cell lymphoma. Int J Cancer. 2025 Jan 15;156(2):251-261. doi: 10.1002/ijc.35156. Epub 2024 Sep 25.
PubMed 39319495Belada D, Kopeckova K, Bergua Burgues JM, Stevens D, Andre M, Persona EP, Pichler P, Staber PB, Trneny M, Duell J, Waldron-Lynch M, Wagner S, Mukhopadhyay A, Dirnberger-Hertweck M, Burke JM, Nowakowski GS. Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study. Blood. 2023 Oct 19;142(16):1348-1358. doi: 10.1182/blood.2023020637.
PubMed 37369099
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04824092
- Acronym / sponsor ID
- frontMIND / MOR208C310
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- DLBCL, CD19, monoclonal antibody, tafasitamab, lenalidomide, R-CHOP, Diffuse Large B-cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 899 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 May 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tafasitamab plus lenalidomide in addition to R-CHOP | Experimental | Drug: Tafasitamab, Drug: Lenalidomide, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: PrednisonePatients 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 |
| Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP | Placebo comparator | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Tafasitamab placebo, Drug: Lenalidomide placeboPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TafasitamabAlso: MonjuviTafasitamab IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Tafasitamab plus lenalidomide in addition to R-CHOP |
| LenalidomideLenalidomide PO will be administered as per the schedule specified in the respective arm. | Drug | Tafasitamab plus lenalidomide in addition to R-CHOP |
| RituximabRituximab IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP, Tafasitamab plus lenalidomide in addition to R-CHOP |
| CyclophosphamideCyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP, Tafasitamab plus lenalidomide in addition to R-CHOP |
| DoxorubicinDoxorubicin IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP, Tafasitamab plus lenalidomide in addition to R-CHOP |
| VincristineVincristine IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP, Tafasitamab plus lenalidomide in addition to R-CHOP |
| PrednisonePrednisone PO will be administered as per the schedule specified in the respective arm. | Drug | Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP, Tafasitamab plus lenalidomide in addition to R-CHOP |
| Tafasitamab placebo0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP |
| Lenalidomide placeboPlacebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm. | Drug | Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP |
Primary outcome
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
10 secondary outcomes
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)
OS
Time frame: 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 at EOT by INV
Time frame: End of treatment, 4-8 weeks after last dose
ORR as per INV at EOT
Time frame: 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)
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)
EFS at 3 years
Time frame: 36 months after randomization
PFS at 3 years
Time frame: 36 months after randomization
OS at 3 years
Time frame: 36 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 42217458Lenz G, Trneny M, Burke JM, Nowakowski GS, Fox CP, Chiappella A, Duell J, Jeon YW, Cheah CY, Westin J, Ye JZ, Caguioa PB, Belada D, Shin HJ, Oh SY, Amorim S, Ku M, Mocikova H, Jimenez JL, Gaidano G, Rosenwald A, Chiarle R, Colucci P, Ioannidis S, Cheng L, Vitolo U; frontMIND Study Investigators. Tafasitamab plus lenalidomide and R-CHOP versus R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma (frontMIND): a global, phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2026 Jun 20;407(10547):2528-2541. doi: 10.1016/S0140-6736(26)00866-4. Epub 2026 May 30.
- Derived from this study: PubMed 40993016Jelicic J, Juul-Jensen K, Bukumiric Z, Runason Simonsen M, Roost Clausen M, Ludvigsen Al-Mashhadi A, Schou Pedersen R, Poulsen CB, Gang AO, Brown P, El-Galaly TC, Stauffer Larsen T. International Prognostic Models as Tools for Selection of Higher-risk Trial-eligible Patients With Diffuse Large B-Cell lymphoma. Clin Lymphoma Myeloma Leuk. 2026 Jan;26(1):e62-e76. doi: 10.1016/j.clml.2025.08.020. Epub 2025 Sep 3.
- Derived from this study: PubMed 39319495Duell J, Westin J. The future of immunotherapy for diffuse large B-cell lymphoma. Int J Cancer. 2025 Jan 15;156(2):251-261. doi: 10.1002/ijc.35156. Epub 2024 Sep 25.
- Derived from this study: PubMed 37369099Belada D, Kopeckova K, Bergua Burgues JM, Stevens D, Andre M, Persona EP, Pichler P, Staber PB, Trneny M, Duell J, Waldron-Lynch M, Wagner S, Mukhopadhyay A, Dirnberger-Hertweck M, Burke JM, Nowakowski GS. Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study. Blood. 2023 Oct 19;142(16):1348-1358. doi: 10.1182/blood.2023020637.
- Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL PatientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Director study director
Incyte Corporation
307 sites in 29 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tafasitamab, Lenalidomide and Rituximab in people with Diffuse Large B-cell Lymphoma, run by Incyte Corporation at 307 sites in 29 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 307 sites in United States, Australia, Germany, Italy, South Korea and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04824092, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.