New combo therapy shows promise for tough-to-treat lymphoma
NCT ID NCT04824092
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding two drugs, tafasitamab and lenalidomide, to standard chemotherapy (R-CHOP) helps people with a fast-growing type of lymphoma called DLBCL. About 900 patients with high-risk disease will take part. The goal is to see if the new combination keeps cancer from coming back longer than standard treatment alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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899 people
The number who actually took part.
- Started
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May 2021
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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MorphoSys Research Site
Daphne, Alabama, 36526, United States
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Anaheim, California, 92801, United States
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Clovis, California, 93611, United States
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Fullerton, California, 92834-4138, United States
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Harbor City, California, 90710, United States
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Los Angeles, California, 90017, United States
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San Diego, California, 92123, United States
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Whittier, California, 90603, United States
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Aurora, Colorado, 80012, United States
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Jacksonville, Florida, 32224, United States
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Honolulu, Hawaii, 96813, United States
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Wichita, Kansas, 67214, United States
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Lexington, Kentucky, 40536-0293, United States
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Louisville, Kentucky, 40241, United States
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Baltimore, Maryland, 21237, United States
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Bethesda, Maryland, 20817-7847, United States
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Columbia, Maryland, 21044, United States
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Detroit, Michigan, 48202, United States
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Minneapolis, Minnesota, 55426, United States
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Rochester, Minnesota, 55905, United States
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Kansas City, Missouri, 64132, United States
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Lebanon, New Hampshire, 03755, United States
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Florham Park, New Jersey, 07932, United States
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Buffalo, New York, 14263, United States
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Rochester, New York, 14642, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45242, United States
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Eugene, Oregon, 97401, United States
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Danville, Pennsylvania, 17822-4910, United States
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Chattanooga, Tennessee, 37404, United States
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Germantown, Tennessee, 38138, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78745, United States
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Bedford, Texas, 76022, United States
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Denison, Texas, 75020, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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McAllen, Texas, 78503, United States
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Tyler, Texas, 75702, United States
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Ogden, Utah, 84405, United States
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Salt Lake City, Utah, 84112, United States
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Gainesville, Virginia, 20155, United States
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Roanoke, Virginia, 24014, United States
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Virginia Beach, Virginia, 23456, United States
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Olympia, Washington, 98502, United States
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Tacoma, Washington, 98405, United States
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Marshfield, Wisconsin, 54449, United States
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Buenos Aires, C1118AAT, Argentina
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Buenos Aires, C1181ACH, Argentina
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Cipolletti, 8324, Argentina
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Rosario, 2000, Argentina
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San Miguel de Tucumán, T4000IVL, Argentina
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Adelaide, 5000, Australia
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Ballarat, 3353, Australia
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Birtinya, 4575, Australia
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Brisbane, 4101, Australia
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Canberra, 2605, Australia
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Clayton, 3168, Australia
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Frankston, VIC 3199, Australia
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Geelong, 3220, Australia
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Gold Coast, QLD 4217, Australia
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Gosford, 2250, Australia
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Greenslopes, 4120, Australia
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Hobart, 7000, Australia
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Kingswood, 2747, Australia
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Kogarah, 2217, Australia
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Launceston, TAS 7250, Australia
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Malvern, 3144, Australia
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Melbourne, 3065, Australia
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Melbourne, 3084, Australia
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Nedlands, 6009, Australia
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Perth, 6000, Australia
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Perth, 6150, Australia
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Richmond, 3121, Australia
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St Albans, 3021, Australia
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Sydney, 2050, Australia
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Sydney, 2145, Australia
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Townsville, 4817, Australia
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Wahroonga, 8833, Australia
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Waratah, 2298, Australia
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Wollongong, 2500, Australia
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Innsbruck, 6020, Austria
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Linz, 4010, Austria
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Linz, 4021, Austria
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Rankweil, 6830, Austria
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Sankt Pölten, 3100, Austria
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Vienna, 1090, Austria
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Vienna, 1140, Austria
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Halifax, B3H 2A7, Canada
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London, N6A 5W9, Canada
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Montreal, H3T 1E2, Canada
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Saskatoon, S7N 4H4, Canada
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Sherbrooke, J1G 2E8, Canada
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Medellín, 050034, Colombia
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Valledupar, 20001, Colombia
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Brno, 625 00, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 775 20, Czechia
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Ostrava, 708 52, Czechia
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Prague, 100 34, Czechia
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Prague, 110 00, Czechia
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Prague, 150 06, Czechia
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Amiens, 14033, France
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Bordeaux, 33074, France
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Bordeaux, 33076, France
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La Tronche, 38700, France
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Le Mans, 72037, France
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Lille, 59020, France
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Limoges, 87042, France
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Marseille, 13385, France
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Nantes, 44093, France
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Poitiers, 86021, France
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Quimper, 29107, France
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Saint-Priest-en-Jarez, 42270, France
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Vandœuvre-lès-Nancy, France
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Vannes, 56017, France
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Aachen, 52074, Germany
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Augsburg, 86156, Germany
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Berlin, 10967, Germany
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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Chemnitz, 09116, Germany
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Cottbus, 03048, Germany
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Göttingen, 37075, Germany
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Halle, 06120, Germany
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Heilbronn, D-74078, Germany
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Jena, 07747, Germany
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Kassel, 34125, Germany
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Lübeck, 23538, Germany
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Magdeburg, 39120, Germany
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Mainz, 55131, Germany
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Marburg, 35043, Germany
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Munich, 81675, Germany
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Munich, 81737, Germany
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Münster, 48149, Germany
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Paderborn, 33098, Germany
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Tübingen, 65199, Germany
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Wiesbaden, 65191, Germany
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Wuppertal, 42283, Germany
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Würzburg, 97080, Germany
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Budapest, 1085, Hungary
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Budapest, H-1122, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Pécs, H-7624, Hungary
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Dublin, Ireland
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Limerick, Ireland
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Beersheba, 8410101, Israel
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Haifa, 31096, Israel
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Jerusalem, 9112001, Israel
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Petah Tikva, 49100, Israel
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Tel Aviv, 6423906, Israel
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Bergamo, 24127, Italy
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Brescia, 25123, Italy
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Candiolo, 10060, Italy
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Catania, 95123, Italy
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Forlì, 47014, Italy
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Genoa, 16132, Italy
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Lecce, 73100, Italy
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Milan, 20141, Italy
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Novara, 28100, Italy
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Orbassano, 10043, Italy
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Padova, 35128, Italy
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Palermo, 90146, Italy
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Pavia, 27100, Italy
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Ravenna, 48121, Italy
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Rimini, 47923, Italy
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Rozzano, 20089, Italy
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Siena, 15121, Italy
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Siena, 53100, Italy
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Terni, 05100, Italy
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Tricase, 73039, Italy
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Trieste, 34129, Italy
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Turin, 10126, Italy
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Fukuoka, 810-8563, Japan
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Gifu, 500-8513, Japan
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Ibaraki, 311-3193, Japan
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Isehara, 259-1193, Japan
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Kagoshima, 890-8520, Japan
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Nagoya, 466-8650, Japan
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Narita-shi, 286-8520, Japan
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Okayama, 701-1192, Japan
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Osaka, 565-0871, Japan
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Osakasayama-shi, 589-8511, Japan
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Sapporo, 003-0804, Japan
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Tachikawa, 190-0014, Japan
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Tokyo, 113-8603, Japan
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Tokyo, 142-8666, Japan
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Tokyo, 162-8666, Japan
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Tsu, 514-8507, Japan
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Alor Star, 05460, Malaysia
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Ampang, 68000, Malaysia
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George Town, 10990, Malaysia
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Ipoh, 30450, Malaysia
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Johor Bahru, 80100, Malaysia
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Kota Bharu, 16150, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuantan, 25100, Malaysia
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Kuching, 93586, Malaysia
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Petaling Jaya, 47500, Malaysia
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Subang Jaya, 47500, Malaysia
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Auckland, 1023, New Zealand
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Manila, 1000, Philippines
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Pasig, 1605, Philippines
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Quezon City, 1112, Philippines
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Warsaw, 02-781, Poland
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Brasov, 500366, Romania
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Bucharest, 050098, Romania
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Iași, 700483, Romania
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Kazan', 420029, Russia
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Novosibirsk, 630087, Russia
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Saint Petersburg, 197341, Russia
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Saint Petersburg, 197758, Russia
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Belgrade, 11 000, Serbia
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Belgrade, 11 080, Serbia
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Kamenitz, 21204, Serbia
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Bratislava, 83310, Slovakia
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Košice, 04166, Slovakia
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Busan, 47392, South Korea
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Busan, 49201, South Korea
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Busan, 4924, South Korea
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Busan, 49267, South Korea
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Daegu, 42415, South Korea
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Daegu, 42472, South Korea
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Daegu, 42601, South Korea
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Goyang-si, 10408, South Korea
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Incheon, South Korea
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Jeonju, 561-712, South Korea
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Jinju, South Korea
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Seoul, 03080, South Korea
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Seoul, 03181, South Korea
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Seoul, 037222, South Korea
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Seoul, 05505, South Korea
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Seoul, 07345, South Korea
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Seoul, 07985, South Korea
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Yangsan, 50612, South Korea
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Badalona, 08916, Spain
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Barcelona, 08035, Spain
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Barcelona, 08908, Spain
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Girona, 17007, Spain
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Jerez de la Frontera, 11407, Spain
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Lugo, 27003, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28050, Spain
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Madrid, 28223, Spain
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Pamplona, 31008, Spain
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Salamanca, 37007, Spain
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Seville, 41009, Spain
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Seville, 41013, Spain
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Seville, 41014, Spain
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Valencia, 46017, Spain
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Vitoria-Gasteiz, 01009, Spain
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Kaohsiung City, 833401, Taiwan
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MorphoSys Research Site
Taichung, 40705, Taiwan
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MorphoSys Research Site
Tainan, 71004, Taiwan
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Taipei, 100226, Taiwan
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MorphoSys Research Site
Bangkok, 10400, Thailand
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Pathum Thani, 12120, Thailand
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MorphoSys Research Site
Ankara, 06590, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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İzmit, 41380, Turkey (Türkiye)
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Malatya, 44280, Turkey (Türkiye)
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Mersin, 33343, Turkey (Türkiye)
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Kyiv, 03115, Ukraine
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Aberdeen, AB25 2ZN, United Kingdom
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Bath, BA1 3NG, United Kingdom
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Birmingham, B15 2TH, United Kingdom
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Bristol, BS2 8ED, United Kingdom
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London, EC1M 6BQ, United Kingdom
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London, SM2 5PT, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Sutton, SW17 0QT, United Kingdom
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Wolverhampton, WV10 0QP, United Kingdom
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Caen, Cedex 9, France
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Bordeau, Pessac Cedax, France
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Le Chesnay, France
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Berlin, Germany
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Nyíregyháza, Hungary
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Ramat Gan, Israel
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Lodz, Poland
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Bucharest, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Moscow, Russia
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Petrozavodsk, Russia
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Saint Petersburg, Russia
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Novi Sad, Serbia
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Chang-hua, Taiwan
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Morphosys Research Site
Chiayi City, 613, Taiwan
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Morphosys Research Site
Hualien City, Taiwan
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Kaohsiung City, Taiwan
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Morphosys Research Site
New Taipei City, Taiwan
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Morphosys Research Site
Taichung, 40447, Taiwan
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Morphosys Research Site
Bangkok, 10500, Thailand
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Morphosys Research Site
Chiang Mai, 50200, Thailand
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Morphosys Research Site
Khon Kaen, 40000, Thailand
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Morphosys Research Site
Cherkasy, 18009, Ukraine
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Morphosys Research Site
Chernihiv, 14029, Ukraine
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Morphosys Research Site
Kharkiv, 61070, Ukraine
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Morphosys Research Site
Kyiv, 03022, Ukraine
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Morphosys Research Site
Kyiv, 03680, Ukraine
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Morphosys Research Site
London, SW3 6JJ, United Kingdom
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Ufa, Russia
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Morphsys Research Site
Taoyuan, Taiwan
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