Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients
NCT ID: NCT04824092
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
899 participants
INTERVENTIONAL
2021-05-11
2027-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Tafasitamab
Tafasitamab IV infusion will be administered as per the schedule specified in the respective arm.
Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
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
Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Tafasitamab placebo
0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm.
Lenalidomide placebo
Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm.
Interventions
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Tafasitamab
Tafasitamab IV infusion will be administered as per the schedule specified in the respective arm.
Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Tafasitamab placebo
0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm.
Lenalidomide placebo
Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Medical Director
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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MorphoSys Research Site
Daphne, Alabama, United States
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Anaheim, California, United States
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Clovis, California, United States
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Fullerton, California, United States
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Harbor City, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Whittier, California, United States
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Aurora, Colorado, United States
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Jacksonville, Florida, United States
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Honolulu, Hawaii, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Columbia, Maryland, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Kansas City, Missouri, United States
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Lebanon, New Hampshire, United States
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Florham Park, New Jersey, United States
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Buffalo, New York, United States
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Rochester, New York, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Eugene, Oregon, United States
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Danville, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Denison, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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McAllen, Texas, United States
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Tyler, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Gainesville, Virginia, United States
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Roanoke, Virginia, United States
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Virginia Beach, Virginia, United States
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Olympia, Washington, United States
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Tacoma, Washington, United States
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Marshfield, Wisconsin, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Cipolletti, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Adelaide, , Australia
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Ballarat, , Australia
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Birtinya, , Australia
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Clayton, , Australia
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Gosford, , Australia
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Greenslopes, , Australia
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Hobart, , Australia
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Kingswood, , Australia
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Kogarah, , Australia
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Launceston, , Australia
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Malvern, , Australia
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Melbourne, , Australia
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Melbourne, , Australia
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Nedlands, , Australia
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Perth, , Australia
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Perth, , Australia
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Richmond, , Australia
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St Albans, , Australia
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Sydney, , Australia
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Sydney, , Australia
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Townsville, , Australia
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Wahroonga, , Australia
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Waratah, , Australia
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Wollongong, , Australia
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Innsbruck, , Austria
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Linz, , Austria
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Linz, , Austria
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Rankweil, , Austria
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Sankt Pölten, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Halifax, , Canada
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London, , Canada
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Montreal, , Canada
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Saskatoon, , Canada
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Sherbrooke, , Canada
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Medellín, , Colombia
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Valledupar, , Colombia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Caen, Cedex 9, France
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Bordeau, Pessac Cedax, France
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Amiens, , France
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Bordeaux, , France
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Bordeaux, , France
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La Tronche, , France
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Le Chesnay, , France
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Le Mans, , France
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Lille, , France
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Limoges, , France
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Marseille, , France
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Nantes, , France
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Poitiers, , France
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Quimper, , France
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Saint-Priest-en-Jarez, , France
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Vandœuvre-lès-Nancy, , France
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Vannes, , France
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Aachen, , Germany
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Augsburg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Chemnitz, , Germany
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Cottbus, , Germany
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Göttingen, , Germany
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Halle, , Germany
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Heilbronn, , Germany
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Jena, , Germany
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Kassel, , Germany
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Lübeck, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Marburg, , Germany
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Munich, , Germany
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Munich, , Germany
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Münster, , Germany
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Paderborn, , Germany
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Tübingen, , Germany
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Wiesbaden, , Germany
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Wuppertal, , Germany
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Würzburg, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Dublin, , Ireland
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Limerick, , Ireland
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Bergamo, , Italy
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Brescia, , Italy
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Candiolo, , Italy
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Catania, , Italy
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Forlì, , Italy
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Genoa, , Italy
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Lecce, , Italy
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Milan, , Italy
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Novara, , Italy
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Orbassano, , Italy
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Padua, , Italy
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Palermo, , Italy
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Pavia, , Italy
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Ravenna, , Italy
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Rimini, , Italy
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Rozzano, , Italy
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Siena, , Italy
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Siena, , Italy
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Terni, , Italy
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Tricase, , Italy
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Trieste, , Italy
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Turin, , Italy
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Fukuoka, , Japan
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Gifu, , Japan
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Ibaraki, , Japan
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Isehara, , Japan
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Kagoshima, , Japan
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Nagoya, , Japan
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Narita-shi, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sapporo, , Japan
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Tachikawa, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tsu, , Japan
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Alor Star, , Malaysia
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Ampang, , Malaysia
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George Town, , Malaysia
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Ipoh, , Malaysia
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Johor Bahru, , Malaysia
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Kota Bharu, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuantan, , Malaysia
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Kuching, , Malaysia
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Petaling Jaya, , Malaysia
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Subang Jaya, , Malaysia
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Auckland, , New Zealand
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Manila, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Lodz, , Poland
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Warsaw, , Poland
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Brasov, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Craiova, , Romania
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Iași, , Romania
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Kazan', , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Petrozavodsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Ufa, , Russia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Novi Sad, , Serbia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Busan, , South Korea
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Busan, , South Korea
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Busan, , South Korea
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Busan, , South Korea
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Daegu, , South Korea
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Daegu, , South Korea
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Daegu, , South Korea
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Goyang-si, , South Korea
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Incheon, , South Korea
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Jeonju, , South Korea
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Jinju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Yangsan, , South Korea
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Badalona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Girona, , Spain
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Jerez de la Frontera, , Spain
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Lugo, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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Salamanca, , Spain
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Seville, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
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Vitoria-Gasteiz, , Spain
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Chang-hua, , Taiwan
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Chiayi City, , Taiwan
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Hualien City, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Khon Kaen, , Thailand
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Pathum Thani, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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İzmit, , Turkey (Türkiye)
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Malatya, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Cherkasy, , Ukraine
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Chernihiv, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Aberdeen, , United Kingdom
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Bath, , United Kingdom
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Birmingham, , United Kingdom
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Bristol, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Nottingham, , United Kingdom
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Sutton, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Jelicic 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. 2025 Sep 3:S2152-2650(25)02889-7. doi: 10.1016/j.clml.2025.08.020. Online ahead of print.
Belada 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.
Other Identifiers
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2022-500237-92-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-002990-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MOR208C310
Identifier Type: -
Identifier Source: org_study_id
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