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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507993-42-00 | Registry Identifier | EU CT Number | |
| 2021-003855-40 | EudraCT Number |
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This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (Tafasitamab + Lenalidomide) | Experimental | Treatment: Tafasitamab will be combined with lenalidomide in R/R DLBCL patients. Dose: Cohort 1: The dose of tafasitamab will be level 1 high dose in combination with the approved dose Cohort 2: The dose of tafasitamab will be level 2 high dose in combination with the approved dose Expansion Cohort: The dose of tafasitamab will be the dose that is deemed safe and tolerable as determined from cohort 1 & cohort 2 Treatment consisting of tafasitamab and lenalidomide combination will be administered until disease progression, unacceptable toxicity, or discontinuation for any other reason, whichever comes first. Lenalidomide can be given for up to 12 cycles in total, after which patients can continue with tafasitamab as monotherapy until progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafasitamab | Drug | tafasitamab will be administered intravenously at protocol defined timepoints |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Therefore, an AE could be any unfavorable or unintended sign (including an abnormal laboratory finding) or symptom temporally associated with the use of study treatment. A TEAE was defined as any AE that started or worsened after the first dose of study treatment until 90 days after the last dose of the study treatment. An AE that was present prior to study drug administration but increased in severity after treatment start was also included as a TEAE. | up to approximately 2 years |
| Number of Participants With Any ≥Grade 3 TEAE | The toxicity grade of TEAEs was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) using the following definitions: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal; local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. | up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ctrough of Tafasitamab After 3 and 12 Treatment Cycles | Ctrough was defined as the minimum concentration of tafasitamab. | predose on Cycle 3 Day 15; predose on Cycle 12 Day 28 (up to approximately 1 year [after twelve 28-day cycles]) |
| Cmax of Tafasitamab After 3 Treatment Cycles |
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Major Inclusion Criteria:
Capable of giving signed informed consent
Age 18 years or older
Histologically confirmed diagnosis of DLBCL
Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study.
Patients must have:
Patients not considered in the opinion of the investigator eligible to undergo intensive salvage therapy including ASCT
Patients must meet the following laboratory criteria at screening:
Patients who received previous CD19 targeted therapy (other than tafasitamab) must have CD19 positive lymphoma confirmed on a biopsy taken since completing the prior CD19 targeted therapy
Patients with primary refractory disease who received at least one, but no more than three previous systemic regimens (including a CD20 targeted therapy)
Major Exclusion Criteria:
Patients who are legally institutionalized or concurrent enrollment in another interventional clinical study
Patients who have:
Patients who have, within 14 days prior to Day 1 dosing:
Patients who:
History of other malignancy that could affect compliance with the protocol or interpretation of results. Exceptions
Patients with:
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
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Director | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morristown Memorial Hospital | Morristown | New Jersey | 07960-6459 | United States | ||
| Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR |
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| Label | URL |
|---|---|
| Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients | View source |
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A total of 53 participants were enrolled at 26 study sites in Austria, Czech Republic, Israel, Italy, Poland, South Korea, Spain, and the United States through the data cutoff date of 17 July 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen. |
| 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 | Apr 11, 2024 | Jul 14, 2025 |
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| Lenalidomide | Drug | lenalidomide will be administered orally at protocol defined timepoints |
|
Cmax was defined as the maximum observed plasma concentration of tafasitamab. |
| 30 minutes after the end of tafasitamab infusion on Cycle 3 Day 15 (up to approximately 85 days [after three 28-day cycles]) |
| Best Objective Response Rate (ORR) by Investigator Assessment up to Treatment Cycle 12 | ORR was defined as the percentage of participants with complete response (CR: disappearance of all evidence disease) or partial response (PR: regression of measurable disease and no new sites) as the best response achieved at any time during the study. Only responses of CR or PR that were documented before the initiation of new antilymphoma therapy (NALT) were considered. Response assessments were based on revised International Working Group response criteria for malignant lymphoma. | up to 19.8 months |
| Duration of Response (DoR) by Investigator Assessment | up to approximately 64 months (approximately 5 years) |
| Progression-free Survival (PFS) by Investigator Assessment | up to approximately 64 months (approximately 5 years) |
| Number of Participants Developing Anti-tafasitamab Antibodies up to Treatment Cycle 12 | Anti-tafasitamab antibody samples were defined as negative if they were screened or confirmed negative. Anti-tafasitamab antibody samples were defined as positive if they were positive in both the screening and the confirmatory assays. | up to approximately 1 year (after twelve 28-day cycles) |
| Dallas |
| Texas |
| 75246-2092 |
| United States |
| Vista Oncology | Olympia | Washington | 98506 | United States |
| UK St. Pölten | Sankt Pölten | Lower Austria | 3100 | Austria |
| Klinikum Wels Grieskirchen | Wels | Upper Austria | 4600 | Austria |
| Universitatsklinikum Salzburg | Salzburg | 5020 | Austria |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava | 708 52 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Vseobecna Fakultni Nemocnice V Praze | Prague | 128 08 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon | Grenoble | Isère | 38043 | France |
| CHU Nantes | Nantes | Loire-Atlantique | 44000 | France |
| Centre Hospitalier Le Mans | Le Mans | Sarthe | 72000 | France |
| CHU de Poitiers | Poitiers | Vienne | 86021 | France |
| Soroka University Medical Centre | Beersheba | Southern District | 84101 | Israel |
| Shamir Medical Center Assaf Harofeh | Be’er Ya‘aqov | 70300 | Israel |
| Lady Davis Carmel Medical Center | Haifa | 34362 | Israel |
| Hadassah Medical Center - Hadassah Ein Kerem | Jerusalem | 91120 | Israel |
| ZIV Medical Center | Safed | 13100 | Israel |
| Ospedale Santa Maria Delle Croci | Ravenna | Emilia-Romagna | 48121 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda | Milan | Lombardy | 20162 | Italy |
| Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia | Lombardy | 27100 | Italy |
| ASST di Monza - Azienda Ospedaliera San Gerardo | Monza | Monza E Brianza | 20900 | Italy |
| Fondazione del Piemonte per l'Oncologia (IRCCS) | Candiolo | Piedmont | 10060 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56127 | Italy |
| Azienda Ospedaliera di Perugia | Perugia | Umbria | 6122 | Italy |
| Centrum Medyczne Poznan - PRATIA - PPDS | Skórzewo | Greater Poland Voivodeship | 60-185 | Poland |
| Pratia MCM Krakow | Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Lower Silesian Voivodeship | 50-367 | Poland |
| Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii | Wroclaw | Lower Silesian Voivodeship | 53-439 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Szpital Wojewodzki w Opolu | Opole | Opole Voivodeship | 45-061 | Poland |
| Szpitale Pomorskie Sp. z o. o. | Gdynia | 81-519 | Poland |
| SP ZOZ Szpital Uniwersytecki w Krakowie | Krakow | 31-501 | Poland |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz | 93-513 | Poland |
| SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie | Olsztyn | 10-228 | Poland |
| Nasz Lekarz Osrodek Badan Klinicznych | Torun | 87-100 | Poland |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | Gyeonggido | 16247 | South Korea |
| Dong-A University Medical Center | Busan | 49201 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Yeungnam University Hospital | Daegu | 42415 | South Korea |
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Chonbuk National University Hospital | Jeonju | 54907 | South Korea |
| Hanyang University Medical Center | Seoul | 4763 | South Korea |
| Asan Medical Center - PPDS | Seoul | 5505 | South Korea |
| The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | 7345 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 7198 | Spain |
| Institut Catala d'Oncologia Girona | Girona | 17007 | Spain |
| ICO l'Hospitalet - Hospital Duran i Reynals | L'Hospitalet de Llobregat | 8907 | Spain |
| Hospital U. Infanta Leonor | Madrid | 28031 | Spain |
| MD Anderson Madrid | Madrid | 28033 | Spain |
| Hospital U. Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital U. Quironsalud Madrid | Madrid | 28223 | Spain |
| Complejo Asistencial Universitario de Salamanca - H. Clinico | Salamanca | 37007 | Spain |
| Hospital U. Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitari La Fe | Valencia | 46026 | Spain |
| FG001 | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen. |
| BG001 | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen. |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Therefore, an AE could be any unfavorable or unintended sign (including an abnormal laboratory finding) or symptom temporally associated with the use of study treatment. A TEAE was defined as any AE that started or worsened after the first dose of study treatment until 90 days after the last dose of the study treatment. An AE that was present prior to study drug administration but increased in severity after treatment start was also included as a TEAE. | Safety Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 postbaseline safety assessment. A valid safety assessment included death. Treatment groups were determined according to the actual treatment the participant received regardless of assigned study treatment. | Posted | Count of Participants | Participants | up to approximately 2 years |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Any ≥Grade 3 TEAE | The toxicity grade of TEAEs was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) using the following definitions: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal; local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. | Safety Analysis Set | Posted | Count of Participants | Participants | up to approximately 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Ctrough of Tafasitamab After 3 and 12 Treatment Cycles | Ctrough was defined as the minimum concentration of tafasitamab. | Pharmacokinetic Analysis Set: all participants who received at least 1 dose of tafasitamab and had at least 1 quantifiable serum tafasitamab concentration. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | micrograms per milliliter (μg/mL) | predose on Cycle 3 Day 15; predose on Cycle 12 Day 28 (up to approximately 1 year [after twelve 28-day cycles]) |
| ||||||||||||||||||||||||||||||
| Secondary | Cmax of Tafasitamab After 3 Treatment Cycles | Cmax was defined as the maximum observed plasma concentration of tafasitamab. | Pharmacokinetic Analysis Set. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | micrograms per milliliter (μg/mL) | 30 minutes after the end of tafasitamab infusion on Cycle 3 Day 15 (up to approximately 85 days [after three 28-day cycles]) |
| ||||||||||||||||||||||||||||||
| Secondary | Best Objective Response Rate (ORR) by Investigator Assessment up to Treatment Cycle 12 | ORR was defined as the percentage of participants with complete response (CR: disappearance of all evidence disease) or partial response (PR: regression of measurable disease and no new sites) as the best response achieved at any time during the study. Only responses of CR or PR that were documented before the initiation of new antilymphoma therapy (NALT) were considered. Response assessments were based on revised International Working Group response criteria for malignant lymphoma. | Full Analysis Set: all participants who received at least 1 dose of study treatment. Participants were analyzed according to the dose group to which they were initially assigned. Confidence intervals were calculated based on the Clopper-Pearson exact method for binomial distributions. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 19.8 months |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) by Investigator Assessment | Not Posted | Nov 2028 | up to approximately 64 months (approximately 5 years) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) by Investigator Assessment | Not Posted | Nov 2028 | up to approximately 64 months (approximately 5 years) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Developing Anti-tafasitamab Antibodies up to Treatment Cycle 12 | Anti-tafasitamab antibody samples were defined as negative if they were screened or confirmed negative. Anti-tafasitamab antibody samples were defined as positive if they were positive in both the screening and the confirmatory assays. | Immunogenicity Analysis Set: all participants who received at least 1 dose of tafasitamab and had at least 1 valid anti-tafasitamab antibody assessment | Posted | Count of Participants | Participants | up to approximately 1 year (after twelve 28-day cycles) |
|
up to approximately 2 years
Adverse events have been reported for the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug and had at least 1 postbaseline safety assessment. A valid safety assessment included death. Treatment groups were determined according to the actual treatment the participant received regardless of assigned study treatment.
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 | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen. | 1 | 6 | 2 | 6 | 6 | 6 |
| EG001 | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen. | 8 | 47 | 20 | 47 | 40 | 47 |
| EG002 | Total | Total | 9 | 53 | 22 | 53 | 46 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchial wall thickening | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Neuroborreliosis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Basal ganglia stroke | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Human polyomavirus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Pityriasis rubra pilaris | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Procedural anxiety | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 24, 2024 | Jul 14, 2025 | 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
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| White |
|
| Unknown |
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Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen. |
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Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen. |
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