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

Sponsor
MorphoSys AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04824092
Collaborator
(none)
880
Enrollment
409
Locations
2
Arms
59.7
Anticipated Duration (Months)
2.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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 previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
880 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
May 11, 2021
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

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: 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.

    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: Vincristine
    Vincristine 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.
    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: Vincristine
    Vincristine 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: 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.

    Outcome Measures

    Primary Outcome Measures

    1. PFS-INV [From randomization to the first occurrence of disease progression or relapse as assessed by the investigator, or death from any cause, whichever occurs earlier (up to 43 months)]

      Progression-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma

    Secondary Outcome Measures

    1. EFS-INV [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

    2. OS [From randomization until the date of death from any cause (up to 62 months)]

      Overall Survival

    3. Metabolic PET-negative CR-rate at EOT by BIRC [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

    4. Metabolic PET-negative CR-rate at EOT by INV [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

    5. MRD status at EOT [6 ± 2 weeks after End of Treatment]

      MRD status by cell-free ctDNA assessment at EOT

    6. PFS at 3 years [36 months after randomization]

      Progression-Free Survival as assessed by the investigator

    7. EFS at 3 years [36 months after randomization]

      Event-Free Survival as assessed by the investigator

    8. OS at 3 years [36 months after randomization]

      Overall Survival

    9. ORR as per INV at EOT [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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. DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma

    8. 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 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 than lower limit of institutional normal range, 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MorphoSys Research Site Birmingham Alabama United States 35209
    2 MorphoSys Research Site Daphne Alabama United States 36526
    3 MorphoSys Research Site Anchorage Alaska United States 99508
    4 MorphoSys Research Site Anchorage Alaska United States 99508
    5 MorphoSys Research Site Chandler Arizona United States 85224
    6 MorphoSys Research Site Tucson Arizona United States 85711
    7 MorphoSys Research Site Tucson Arizona United States 85719
    8 MorphoSys Research Site Jonesboro Arkansas United States 72401
    9 Morphosys Research Site Jonesboro Arkansas United States 72401
    10 MorphoSys Research Site Anaheim California United States 92801
    11 MorphoSys Research Site Bakersfield California United States 92123
    12 MorphoSys Research Site Berkeley California United States 94704
    13 MorphoSys Research Site Clovis California United States 93611
    14 MorphoSys Research Site Fountain Valley California United States 92708
    15 MorphoSys Research Site Fullerton California United States 92834-4138
    16 MorphoSys Research Site Harbor City California United States 90710
    17 MorphoSys Research Site Los Alamitos California United States 90720
    18 MorphoSys Research Site Los Angeles California United States 90017
    19 MorphoSys Research Site Los Angeles California United States 90033
    20 MorphoSys Research Site Los Angeles California United States 90048
    21 MorphoSys Research Site Los Angeles California United States 90404
    22 MorphoSys Research Site San Diego California United States 92123
    23 MorphoSys Research Site Santa Barbara California United States 93105
    24 MorphoSys Research Site West Hollywood California United States 33176
    25 MorphoSys Research Site Whittier California United States 90603
    26 MorphoSys Research Site Aurora Colorado United States 80012
    27 MorphoSys Research Site Grand Junction Colorado United States 81501
    28 MorphoSys Research Site Newark Delaware United States 19713
    29 MorphoSys Research Site Jacksonville Florida United States 32207
    30 MorphoSys Research Site Jacksonville Florida United States 32224
    31 MorphoSys Research Site Miami Lakes Florida United States 33014
    32 MorphoSys Research Site Orange City Florida United States 32763
    33 MorphoSys Research Site Atlanta Georgia United States 30341
    34 MorphoSys Research Site Marietta Georgia United States 30060
    35 MorphoSys Research Site Honolulu Hawaii United States 96813
    36 MorphoSys Research Site Coeur d'Alene Idaho United States 83814
    37 MorphoSys Research Site Chicago Illinois United States 60607
    38 MorphoSys Research Site Chicago Illinois United States 60612
    39 MorphoSys Research Site Maywood Illinois United States 60153
    40 MorphoSys Research Site Niles Illinois United States 60714
    41 MorphoSys Research Site Skokie Illinois United States 60076
    42 MorphoSys Research Site Wichita Kansas United States 67214
    43 MorphoSys Research Site Lexington Kentucky United States 40536-0293
    44 MorphoSys Research Site Louisville Kentucky United States 40241
    45 MorphoSys Research Site New Orleans Louisiana United States 70112
    46 MorphoSys Research Site Shreveport Louisiana United States 71103
    47 MorphoSys Research Site Baltimore Maryland United States 21237
    48 MorphoSys Research Site Bethesda Maryland United States 20817-7847
    49 MorphoSys Research Site Columbia Maryland United States 21044
    50 MorphoSys Research Site Frederick Maryland United States 21702
    51 MorphoSys Research Site Boston Massachusetts United States 02215
    52 MorphoSys Research Site Detroit Michigan United States 48202
    53 MorphoSys Research Site Farmington Hills Michigan United States 48334
    54 MorphoSys Research Site Southfield Michigan United States 48075
    55 MorphoSys Research Site Sterling Heights Michigan United States 48314
    56 MorphoSys Research Site Minneapolis Minnesota United States 55426
    57 MorphoSys Research Site Rochester Minnesota United States 55905
    58 MorphoSys Research Site Kansas City Missouri United States 64132
    59 MorphoSys Research Site Billings Montana United States 59102
    60 MorphoSys Research Site Omaha Nebraska United States 68130
    61 MorphoSys Research Site Las Vegas Nevada United States 89144
    62 MorphoSys Research Site Las Vegas Nevada United States 89148-6702
    63 MorphoSys Research Site Lebanon New Hampshire United States 03755
    64 MorphoSys Research Site Florham Park New Jersey United States 07932
    65 MorphoSys Research Site Morristown New Jersey United States 07962
    66 MorphoSys Research Site Bronx New York United States 10467
    67 MorphoSys Research Site Buffalo New York United States 14263
    68 MorphoSys Research Site Hawthorne New York United States 10595
    69 MorphoSys Research Site Johnson City New York United States 13790
    70 MorphoSys Research Site New York New York United States 10029-6574
    71 MorphoSys Research Site Oneida New York United States 13421
    72 MorphoSys Research Site Rochester New York United States 14642
    73 MorphoSys Research Site Asheville North Carolina United States 28806
    74 MorphoSys Research Site Canton Ohio United States 44718
    75 MorphoSys Research Site Cincinnati Ohio United States 45219
    76 MorphoSys Research Site Cincinnati Ohio United States 45242
    77 MorphoSys Research Site Oklahoma City Oklahoma United States 73142
    78 MorphoSys Research Site Eugene Oregon United States 97401
    79 MorphoSys Research Site Danville Pennsylvania United States 17822-4910
    80 MorphoSys Research Site Pittsburgh Pennsylvania United States 15224
    81 MorphoSys Research Site Charleston South Carolina United States 29414
    82 MorphoSys Research Site Greenville South Carolina United States 29607
    83 MorphoSys Research Site Greenville South Carolina United States 29615
    84 MorphoSys Research Site Sioux Falls South Dakota United States 57104
    85 MorphoSys Research Site Chattanooga Tennessee United States 37404
    86 MorphoSys Research Site Germantown Tennessee United States 38138
    87 MorphoSys Research Site Germantown Tennessee United States 60068
    88 MorphoSys Research Site Nashville Tennessee United States 37203
    89 MorphoSys Research Site Austin Texas United States 78745
    90 MorphoSys Research Site Bedford Texas United States 76022
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    96 MorphoSys Research Site Houston Texas United States 77030-1501
    97 MorphoSys Research Site Houston Texas United States 77030
    98 MorphoSys Research Site Houston Texas United States 77056
    99 MorphoSys Research Site McAllen Texas United States 78503
    100 MorphoSys Research Site Plano Texas United States 75075-778
    101 MorphoSys Research Site Sugar Land Texas United States 77479
    102 MorphoSys Research Site Tyler Texas United States 75702
    103 MorphoSys Research Site Ogden Utah United States 84405
    104 MorphoSys Research Site Salt Lake City Utah United States 84112
    105 MorphoSys Research Site Gainesville Virginia United States 20155
    106 MorphoSys Research Site Roanoke Virginia United States 24014
    107 MorphoSys Research Site Virginia Beach Virginia United States 23456
    108 MorphoSys Research Site Everett Washington United States 98201
    109 MorphoSys Research Site Olympia Washington United States 98502
    110 MorphoSys Research Site Seattle Washington United States 98108
    111 MorphoSys Research Site Tacoma Washington United States 98405
    112 MorphoSys Research Site Marshfield Wisconsin United States 54449
    113 MorphoSys Research Site Buenos Aires Argentina 1426
    114 MorphoSys Research Site Buenos Aires Argentina C1118AAT
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    116 MorphoSys Research Site Mendoza Argentina 5500
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    120 MorphoSys Research Site Ballarat Australia 3353
    121 MorphoSys Research Site Birtinya Australia 4575
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    124 MorphoSys Research Site Canberra Australia 2605
    125 MorphoSys Research Site Clayton Australia 3168
    126 MorphoSys Research Site Darlinghurst Australia 2010
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    128 MorphoSys Research Site Frankston Australia VIC 3199
    129 MorphoSys Research Site Geelong Australia 3220
    130 MorphoSys Research Site Gold Coast Australia QLD 4217
    131 MorphoSys Research Site Gosford Australia 2250
    132 MorphoSys Research Site Greenslopes Australia 4120
    133 MorphoSys Research Site Hobart Australia 7000
    134 MorphoSys Research Site Kingswood Australia 2747
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    137 MorphoSys Research Site Liverpool Australia 2170
    138 MorphoSys Research Site Malvern Australia 3144
    139 MorphoSys Research Site Melbourne Australia 3021
    140 MorphoSys Research Site Melbourne Australia 3065
    141 MorphoSys Research Site Melbourne Australia 3128
    142 MorphoSys Research Site Nedlands Australia 6009
    143 MorphoSys Research Site Perth Australia 6000
    144 MorphoSys Research Site Perth Australia 6150
    145 MorphoSys Research Site Richmond Australia 3121
    146 MorphoSys Research Site Sydney Australia 2050
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    148 MorphoSys Research Site Townsville Australia 4817
    149 MorphoSys Research Site Wahroonga Australia 8833
    150 MorphoSys Research Site Waratah Australia 2298
    151 MorphoSys Research Site Wollongong Australia 2500
    152 MorphoSys Research Site Innsbruck Austria 6020
    153 MorphoSys Research Site Linz Austria 4010
    154 MorphoSys Research Site Linz Austria 4021
    155 MorphoSys Research Site Rankweil Austria 6830
    156 MorphoSys Research Site St. Poelten Austria 3100
    157 MorphoSys Research Site Vienna Austria 1090
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    159 MorphoSys Research Site Edmonton Canada T6G 1Z2
    160 MorphoSys Research Site Halifax Canada B3H 2A7
    161 MorphoSys Research Site London Canada N6A 5W9
    162 MorphoSys Research Site Montreal Canada H3T 1E2
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    165 MorphoSys Research Site Cali Colombia 490042
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    168 MorphoSys Research Site Valledupar Colombia 20001
    169 MorphoSys Research Site Brno Czechia 625 00
    170 MorphoSys Research Site Hradec Králové Czechia 500 05
    171 MorphoSys Research Site Olomouc Czechia 775 20
    172 MorphoSys Research Site Ostrava Czechia 708 52
    173 MorphoSys Research Site Prague Czechia 100 34
    174 MorphoSys Research Site Prague Czechia 110 00
    175 MorphoSys Research Site Prague Czechia 150 06
    176 Morphosys Research Site Caen Cedex 9 France
    177 Morphosys Research Site Bordeau Pessac Cedax France
    178 MorphoSys Research Site Bordeaux France 33076
    179 MorphoSys Research Site Dijon France 21079
    180 MorphoSys Research Site La Tronche France 38700
    181 Morphosys Research Site Le Chesnay France
    182 MorphoSys Research Site Le Mans France 72037
    183 MorphoSys Research Site Lille France 59020
    184 MorphoSys Research Site Limoges France 87042
    185 MorphoSys Research Site Marseille France 13385
    186 MorphoSys Research Site Montpellier France 34295
    187 MorphoSys Research Site Nantes France 44093
    188 MorphoSys Research Site Pierre-Benite France 69495
    189 MorphoSys Research Site Quimper France 29107
    190 MorphoSys Research Site Saint Brieuc France 22027
    191 MorphoSys Research Site Saint-Priest-en-Jarez France 42270
    192 MorphoSys Research Site Vandoeuvre-lès-Nancy France
    193 MorphoSys Research Site Vannes France 56017
    194 MorphoSys Research Site Aachen Germany 52074
    195 MorphoSys Research Site Augsburg Germany 86156
    196 MorphoSys Research Site Berlin Germany 10117
    197 MorphoSys Research Site Berlin Germany 10967
    198 Morphosys Research Site Berlin Germany
    199 MorphoSys Research Site Bochum Germany 44791
    200 MorphoSys Research Site Bonn Germany 53127
    201 MorphoSys Research Site Chemnitz Germany 09116
    202 MorphoSys Research Site Cottbus Germany Cottbus
    203 MorphoSys Research Site Göttingen Germany 37073
    204 MorphoSys Research Site Halle Germany 06120
    205 MorphoSys Research Site Heilbronn Germany D-74078
    206 MorphoSys Research Site Jena Germany 07747
    207 MorphoSys Research Site Kassel Germany 34125
    208 MorphoSys Research Site Mainz Germany 55131
    209 MorphoSys Research Site Marburg Germany 35043
    210 MorphoSys Research Site Muenster Germany 48149
    211 MorphoSys Research Site Munich Germany 81675
    212 MorphoSys Research Site Munich Germany 81737
    213 MorphoSys Research Site Mutlangen Germany 73557
    214 MorphoSys Research Site Nuernberg Germany 90419
    215 MorphoSys Research Site Paderborn Germany 33098
    216 MorphoSys Research Site Rostock Germany 18057
    217 MorphoSys Research Site Wiesbaden Germany 65191
    218 MorphoSys Research Site Wuerzburg Germany 97080
    219 MorphoSys Research Site Budapest Hungary 1085
    220 MorphoSys Research Site Budapest Hungary H-1097
    221 MorphoSys Research Site Budapest Hungary H-1122
    222 Morphosys Research Site Budapest Hungary
    223 MorphoSys Research Site Debrecen Hungary 4032
    224 MorphoSys Research Site Gyor Hungary 9024
    225 MorphoSys Research Site Kecskemet Hungary H-6000
    226 Morphosys Research Site Nyíregyháza Hungary
    227 MorphoSys Research Site Pécs Hungary H-7624
    228 MorphoSys Research Site Szeged Hungary H-6725
    229 MorphoSys Research Site Dublin Ireland
    230 MorphoSys Research Site Dublin Ireland
    231 MorphoSys Research Site Galway City Ireland
    232 MorphoSys Research Site Limerick Ireland
    233 MorphoSys Research Site Be'er Sheva Israel 8410101
    234 MorphoSys Research Site Haifa Israel 31096
    235 MorphoSys Research Site Jerusalem Israel 9112001
    236 MorphoSys Research Site Petah-Tikva Israel 49100
    237 Morphosys Research Site Ramat Gan Israel
    238 MorphoSys Research Site Tel Hashomer Israel 5262000
    239 MorphoSys Research Site Tel-Aviv Israel 6423906
    240 MorphoSys Research Site Alessandria Italy 15100
    241 MorphoSys Research Site Bari Italy 70124
    242 MorphoSys Research Site Bergamo Italy 24127
    243 MorphoSys Research Site Bologna Italy 40138
    244 MorphoSys Research Site Brescia Italy 25123
    245 MorphoSys Research Site Candiolo Italy 10060
    246 MorphoSys Research Site Catania Italy 95123
    247 MorphoSys Research Site Forli Italy 47014
    248 MorphoSys Research Site Genoa Italy 16132
    249 MorphoSys Research Site Lecce Italy 73100
    250 MorphoSys Research Site Milan Italy 20133
    251 MorphoSys Research Site Milan Italy 20141
    252 MorphoSys Research Site Novara Italy 28100
    253 MorphoSys Research Site Orbassano Italy 10043
    254 MorphoSys Research Site Padova Italy 35128
    255 MorphoSys Research Site Palermo Italy 90146
    256 MorphoSys Research Site Pavia Italy 27100
    257 MorphoSys Research Site Ravenna Italy 48121
    258 MorphoSys Research Site Rimini Italy 47923
    259 MorphoSys Research Site Rome Italy 00189
    260 MorphoSys Research Site Rozzano Italy 20089
    261 MorphoSys Research Site Siena Italy 53100
    262 MorphoSys Research Site Terni Italy 05100
    263 MorphoSys Research Site Tricase Italy 73039
    264 MorphoSys Research Site Trieste Italy 34129
    265 MorphoSys Research Site Turin Italy 10126
    266 MorphoSys Research Site Turin Italy 10128
    267 MorphoSys Research Site Chiba Japan 260-8717
    268 MorphoSys Research Site Fukuoka Japan 810-8563
    269 MorphoSys Research Site Gifu Japan 500-8513
    270 MorphoSys Research Site Ibaraki Japan 311-3193
    271 MorphoSys Research Site Isehara Japan 259-1193
    272 MorphoSys Research Site Kagoshima Japan 890-8520
    273 MorphoSys Research Site Kanazawa Japan 920-8641
    274 MorphoSys Research Site Kashiwa-shi Japan 227-8577
    275 MorphoSys Research Site Kobe Japan 650-0047
    276 MorphoSys Research Site Matsuyama Japan 791-0280
    277 MorphoSys Research Site Nagoya Japan 466-8650
    278 MorphoSys Research Site Narita-shi Japan 286-8520
    279 MorphoSys Research Site Okayama Japan 701-1192
    280 MorphoSys Research Site Osakasayama-shi Japan 589-8511
    281 MorphoSys Research Site Osaka Japan 565-0871
    282 MorphoSys Research Site Saitama Japan 350-0495
    283 MorphoSys Research Site Sapporo Japan 003-0804
    284 MorphoSys Research Site Sendai Japan 980-8574
    285 MorphoSys Research Site Tachikawa Japan 190-0014
    286 MorphoSys Research Site Tokyo Japan 113-8603
    287 MorphoSys Research Site Tokyo Japan 142-8666
    288 MorphoSys Research Site Tokyo Japan 162-8666
    289 MorphoSys Research Site Tsu-shi Japan 514-8507
    290 MorphoSys Research Site Yamagata Japan 990-9585
    291 MorphoSys Research Site Yokohama Japan 241-8515
    292 MorphoSys Research Site Busan Korea, Republic of 49201
    293 MorphoSys Research Site Busan Korea, Republic of 602-739
    294 MorphoSys Research Site Goyang-si Korea, Republic of 10408
    295 MorphoSys Research Site Incheon Korea, Republic of
    296 MorphoSys Research Site Jeonju Korea, Republic of 561-712
    297 MorphoSys Research Site Seongnam-si Korea, Republic of 13620
    298 MorphoSys Research Site Seoul Korea, Republic of 03080
    299 MorphoSys Research Site Seoul Korea, Republic of 05505
    300 MorphoSys Research Site Seoul Korea, Republic of 06351
    301 MorphoSys Research Site Seoul Korea, Republic of 06591
    302 MorphoSys Research Site Ulsan Korea, Republic of
    303 MorphoSys Research Site Alor Setar Malaysia 05460
    304 MorphoSys Research Site Ampang Malaysia 68000
    305 MorphoSys Research Site George Town Malaysia 10990
    306 MorphoSys Research Site Ipoh Malaysia 30450
    307 MorphoSys Research Site Kota Bharu Malaysia 16150
    308 MorphoSys Research Site Kuala Lumpur Malaysia 59100
    309 MorphoSys Research Site Kuantan Malaysia 25100
    310 MorphoSys Research Site Kuching Malaysia 93586
    311 MorphoSys Research Site Petaling Jaya Malaysia 47500
    312 MorphoSys Research Site Subang Jaya Malaysia 47500
    313 MorphoSys Research Site Taiping Malaysia 34000
    314 MorphoSys Research Site Auckland New Zealand 1023
    315 MorphoSys Research Site Bacolod City Philippines 6100
    316 MorphoSys Research Site Cebu City Philippines 6000
    317 MorphoSys Research Site Davao City Philippines 8000
    318 MorphoSys Research Site Manila Philippines 1000
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    320 MorphoSys Research Site Quezon City Philippines 1112
    321 MorphoSys Research Site Krakow Poland 30-510
    322 Morphosys Research Site Piła Poland
    323 MorphoSys Research Site Torun Poland 87-100
    324 MorphoSys Research Site Warsaw Poland 02-781
    325 Morphosys Research Site Łódź Poland
    326 MorphoSys Research Site Brasov Romania 500366
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    Sponsors and Collaborators

    • MorphoSys AG

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MorphoSys AG
    ClinicalTrials.gov Identifier:
    NCT04824092
    Other Study ID Numbers:
    • MOR208C310
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by MorphoSys AG
    DLBCL
    CD19
    monoclonal antibody
    tafasitamab
    lenalidomide
    R-CHOP
    Diffuse Large B-cell Lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse
    Prednisone
    Cyclophosphamide
    Rituximab
    Doxorubicin
    Vincristine
    Lenalidomide

    Study Results

    No Results Posted as of Aug 24, 2022