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This is an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Tafasitamab in addition to R-CHOP |
|
| Arm B | Experimental | Tafasitamab plus lenalidomide in addition to R-CHOP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafasitamab | Drug | Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) | 6 months approximately |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) at the End of Treatment (EOT) | The ORR at EOT was defined as the proportion of patients with Complete Response (CR) or Partial response (PR) based on the response achieved at the EOT Visit/early treatment discontinuation visit. | 6 months approximately |
| Metabolic, PET-negative Complete Response (CR) Rate at the End of Treatment |
Not provided
Major Inclusion Criteria:
Age >18 years
Histologically confirmed diagnosis of DLBCL, not otherwise specified (NOS)
Tumor tissue for retrospective central pathology review and correlative studies must be provided.
At least one bidimensionally measurable, PET positive disease site (greatest transverse diameter of ≥1.5 cm, greatest perpendicular diameter of ≥1.0 cm)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
International Prognostic Index (IPI) status of 2 to 5
Appropriate candidate for R-CHOP
Left ventricular ejection fraction (LVEF) of ≥50% assessed by echocardiography or cardiac multi-gated acquisition (MUGA) scan
Adequate hematologic, liver and renal function
Females of childbearing potential (FCBP) must:
Males must:
In the opinion of investigator, the patient must be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
Major Exclusion Criteria:
Any other histological type of lymphoma according to World Health Organization (WHO) 2016 classification of lymphoid neoplasms, known double- or triple-hit lymphoma
Transformed non-Hodgkin lymphoma (NHL) and/or evidence of composite lymphoma
History of radiation therapy to ≥25% of the bone marrow or history of anthracycline therapy
History of prior non-hematologic malignancy except for the following:
History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening arrhythmias
Patients with:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MorphoSys Research Site | Tucson | Arizona | 85711 | United States | ||
| MorphoSys Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40802906 | Derived | Roschewski M, Kurtz DM, Westin JR, Lynch RC, Gopal AK, Alig SK, Sworder BJ, Cherng HJ, Kuffer C, Blair D, Brown K, Goldstein JS, Schultz A, Close S, Chabon JJ, Diehn M, Wilson WH, Alizadeh AA. Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma. J Clin Oncol. 2025 Dec;43(34):3652-3661. doi: 10.1200/JCO-25-01534. Epub 2025 Aug 13. | |
| 37369099 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP |
| FG001 | Arm B | Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 5, 2020 | Aug 16, 2023 |
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| Tafasitamab plus lenalidomide | Drug | Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP |
|
| 6 months approximately |
| Incidence and Severity of Adverse Events (AEs) in the Follow-up (FU) Period | 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events |
| Best Objective Response Rate (ORR) Until the End of Study (EOS) | The best ORR was defined as the proportion of patients with Complete Response (CR) or Partial Response (PR) as the best response until the EOS. | 24 months approximately |
| Metabolic, PET-negative Complete Response (CR) Rate Until the End of Study | 24 months approximately |
| Progression-free Survival (PFS) at 12 and 24 Months | As many patients had their data censored, due to completing the study without disease progression or death due to any cause, the probability of PFS (%) was used. | 24 months approximately |
| Event-free Survival (EFS) at 12 and 24 Months | As many patients had their data censored, due to completing the study without disease progression, death due to any cause, or the start of a new anti-lymphoma treatment, the probability of EFS (%) was used. | 24 months approximately |
| Time to Next Anti-lymphoma Treatment (TTNT) | As many patients had their data censored, due to completing the study without needing to receive another anti-lymphoma treatment, the Probability of TTNT (%) was used. Time to next anti-lymphoma treatment survival % estimate was the estimated probability that a patient remained TTNT-free up to the specified point in time. | 24 months approximately |
| Overall Survival at 12 and 24 Months | As many patients had their data censored, due to completing the study without death from any cause, the probability of OS (%) was used. | 24 months approximately |
| Anti-tafasitamab Antibodies Formation | 12 months approximately |
| Anaheim |
| California |
| 92801 |
| United States |
| MorphoSys Research Site | Duarte | California | 91010 | United States |
| MorphoSys Research Site | Encinitas | California | 92024 | United States |
| MorphoSys Research Site | Aurora | Colorado | 80012 | United States |
| MorphoSys Research Site | New Haven | Connecticut | 06520 | United States |
| MorphoSys Research Site | Washington D.C. | District of Columbia | 20037 | United States |
| MorphoSys Research Site | Urbana | Illinois | 61801 | United States |
| MorphoSys Research Site | Louisville | Kentucky | 40207 | United States |
| MorphoSys Research Site | Covington | Louisiana | 70433 | United States |
| MorphoSys Research Site | Rockville | Maryland | 20850 | United States |
| MorphoSys Research Site | Ann Arbor | Michigan | 48109-5864 | United States |
| MorphoSys Research Site | Rochester | Minnesota | 55905 | United States |
| MorphoSys Research Site | Cincinnati | Ohio | 45236 | United States |
| MorphoSys Research Site | Cleveland | Ohio | 44106 | United States |
| MorphoSys Research Site | Eugene | Oregon | 97401 | United States |
| MorphoSys Research Site | Charleston | South Carolina | 29425 | United States |
| MorphoSys Research Site | Austin | Texas | 78705 | United States |
| MorphoSys Research Site | Dallas | Texas | 75246 | United States |
| MorphoSys Research Site | Houston | Texas | 77030 | United States |
| MorphoSys Research Site | San Antonio | Texas | 78240 | United States |
| MorphoSys Research Site | Tyler | Texas | 75702 | United States |
| MorphoSys Research Site | Vancouver | Washington | 98684 | United States |
| MorphoSys Research Site | Graz | A-8036 | Austria |
| MorphoSys Research Site | Innsbruck | 6020 | Austria |
| MorphoSys Research Site | Linz | 4010 | Austria |
| MorphoSys Research Site | Salzburg | 5020 | Austria |
| MorphoSys Research Site | Sankt Pölten | 3100 | Austria |
| MorphoSys Research Site | Vienna | 1090 | Austria |
| MorphoSys Research Site | Wels | 4600 | Austria |
| MorphoSys Research Site | Antwerp | 2060 | Belgium |
| MorphoSys Research Site | Antwerp | 2610 | Belgium |
| MorphoSys Research Site | Brussels | 1090 | Belgium |
| MorphoSys Research Site | Ghent | 9000 | Belgium |
| MorphoSys Research Site | Roeselare | 8800 | Belgium |
| MorphoSys Research Site | Yvoir | 5530 | Belgium |
| MorphoSys Research Site | Hradec Králové | 50005 | Czechia |
| MorphoSys Research Site | Ostrava | 708 52 | Czechia |
| MorphoSys Research Site | Prague | 100 34 | Czechia |
| MorphoSys Research Site | Prague | 12808 | Czechia |
| MorphoSys Research Site | Prague | 15006 | Czechia |
| MorphoSys Research Site | Bordeaux | France |
| MorphoSys Research Site | Brest | France |
| MorphoSys Research Site | Nantes | France |
| MorphoSys Research Site | Pierre-Bénite | France |
| MorphoSys Research Site | Aachen | 52074 | Germany |
| MorphoSys Research Site | Augsburg | 86156 | Germany |
| MorphoSys Research Site | Bonn | 53127 | Germany |
| MorphoSys Research Site | Dortmund | 44137 | Germany |
| MorphoSys Research Site | Giessen | 35391 | Germany |
| MorphoSys Research Site | Göttingen | 37075 | Germany |
| MorphoSys Research Site | Halle | 6120 | Germany |
| MorphoSys Research Site | Mutlangen | 73557 | Germany |
| MorphoSys Research Site | München | 80634 | Germany |
| MorphoSys Research Site | München | 81377 | Germany |
| MorphoSys Research Site | Nuremberg | 90419 | Germany |
| MorphoSys Research Site | Würzburg | 97080 | Germany |
| MorphoSys Research Site | Bologna | Italy |
| MorphoSys Research Site | Ravenna | Italy |
| MorphoSys Research Site | Lisbon | 1099-023 | Portugal |
| MorphoSys Research Site | Lisbon | 1400-038 | Portugal |
| MorphoSys Research Site | Porto | 4200-072 | Portugal |
| MorphoSys Research Site | Porto | 4200-319 | Portugal |
| MorphoSys Research Site | Barcelona | Spain |
| MorphoSys Research Site | Cáceres | Spain |
| MorphoSys Research Site | Girona | Spain |
| MorphoSys Research Site | Madrid | Spain |
| MorphoSys Research Site | Sabadell | Spain |
| MorphoSys Research Site | Seville | Spain |
| MorphoSys Research Site | Vitoria-Gasteiz | Spain |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP |
| BG001 | Arm B | Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Weight at Baseline (kg) | Mean | Standard Deviation | kg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) | No participants in the "Arm A" Group were assessed for the "Patients with TEAE related to Lenalidomide only" row, since they did not receive Lenalidomide. | Posted | Count of Participants | Participants | 6 months approximately |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) at the End of Treatment (EOT) | The ORR at EOT was defined as the proportion of patients with Complete Response (CR) or Partial response (PR) based on the response achieved at the EOT Visit/early treatment discontinuation visit. | Posted | Count of Participants | Participants | 6 months approximately |
|
| |||||||||||||||||||||||||||||||
| Secondary | Metabolic, PET-negative Complete Response (CR) Rate at the End of Treatment | Posted | Count of Participants | Participants | 6 months approximately |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Incidence and Severity of Adverse Events (AEs) in the Follow-up (FU) Period | Posted | Count of Participants | Participants | 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Best Objective Response Rate (ORR) Until the End of Study (EOS) | The best ORR was defined as the proportion of patients with Complete Response (CR) or Partial Response (PR) as the best response until the EOS. | Posted | Count of Participants | Participants | 24 months approximately |
|
| |||||||||||||||||||||||||||||||
| Secondary | Metabolic, PET-negative Complete Response (CR) Rate Until the End of Study | Posted | Count of Participants | Participants | 24 months approximately |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) at 12 and 24 Months | As many patients had their data censored, due to completing the study without disease progression or death due to any cause, the probability of PFS (%) was used. | Posted | Number | 95% Confidence Interval | percent | 24 months approximately |
|
| ||||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) at 12 and 24 Months | As many patients had their data censored, due to completing the study without disease progression, death due to any cause, or the start of a new anti-lymphoma treatment, the probability of EFS (%) was used. | Posted | Number | 95% Confidence Interval | percent | 24 months approximately |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Next Anti-lymphoma Treatment (TTNT) | As many patients had their data censored, due to completing the study without needing to receive another anti-lymphoma treatment, the Probability of TTNT (%) was used. Time to next anti-lymphoma treatment survival % estimate was the estimated probability that a patient remained TTNT-free up to the specified point in time. | Posted | Number | 95% Confidence Interval | percent | 24 months approximately |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival at 12 and 24 Months | As many patients had their data censored, due to completing the study without death from any cause, the probability of OS (%) was used. | Posted | Number | 95% Confidence Interval | percent | 24 months approximately |
|
| ||||||||||||||||||||||||||||||
| Secondary | Anti-tafasitamab Antibodies Formation | One patient in the Tafasitamab in addition to R-CHOP arm (Arm A) was missing a baseline sample and therefore could not be included in this analysis. In addition, no post-baseline evaluation was available for one patient in Arm A and one patient in Arm B hence the number of analyzed participants differs from overall. | Posted | Count of Participants | Participants | 12 months approximately |
|
|
18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events, and approximately 24 months for all-cause mortality.
Any AE reported from the treatment start date through 30 days after the last dose of treatment end date.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | Tafasitamab in addition to R-CHOP Tafasitamab: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP | 4 | 33 | 14 | 33 | 31 | 33 |
| EG001 | Arm B | Tafasitamab plus lenalidomide in addition to R-CHOP Tafasitamab plus lenalidomide: Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP | 2 | 33 | 17 | 33 | 32 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Generalized tonic-clonic seizure | Nervous system disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Device-related thrombosis | General disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Paraspinal abscess | Infections and infestations | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Retroperitoneal abscess | Infections and infestations | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Infusion-related reaction | Injury, poisoning and procedural complications | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Infusion-related reaction | Injury, poisoning and procedural complications | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA, Version 24.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA, Version 24.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA, Version 24.0 | Systematic Assessment |
|
No investigator or institution may publish any results of the trial conducted at their site, before a first multicentre publication is made which covers the data from all sites. The author must coordinate the publication with the sponsor, who has the right to review it at least 60 days before their submission. If publication would affect the patentability of any invention to which the sponsor has rights, the sponsor can request to delay the proposed publication for no more than 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | MorphoSys | +1 844 667-1992 | medinfo@morphosys.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2022 | Sep 11, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613469 | tafasitamab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| 65-84 years |
|
| Greater than or equal to 85 years |
|
| Male |
|
| Other |
|
| Not Reported |
|
| Patients with any study treatment-related TEAE |
|
|
| Patients with TEAE related to Tafasitamab only |
|
|
| Patients with TEAE related to Lenalidomide only |
|
|
| Patients with TEAE related to R-CHOP only |
|
|
| Patients with any grade ≥3 TEAE |
|
|
| Patients with any serious TEAE |
|
|
|
|
|
|
|
|
|
|
|
|