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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
tafasitamab will be administered intravenously at protocol defined timepoints
lenalidomide will be administered orally at protocol defined timepoints
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.
Time frame: 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.
Time frame: up to approximately 2 years
Ctrough of Tafasitamab After 3 and 12 Treatment Cycles
Ctrough was defined as the minimum concentration of tafasitamab.
Time frame: 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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Morristown Memorial Hospital
Morristown, New Jersey, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR
Dallas, Texas, United States
Vista Oncology
Olympia, Washington, United States
UK St. Pölten
Sankt Pölten, Lower Austria, Austria
Klinikum Wels Grieskirchen
Wels, Upper Austria, Austria
Universitatsklinikum Salzburg
Salzburg, Austria
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice Ostrava
Ostrava, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
...and 52 more locations
Cmax was defined as the maximum observed plasma concentration of tafasitamab.
Time frame: 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.
Time frame: up to 19.8 months
Duration of Response (DoR) by Investigator Assessment
Time frame: up to approximately 64 months (approximately 5 years)
Progression-free Survival (PFS) by Investigator Assessment
Time frame: 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.
Time frame: up to approximately 1 year (after twelve 28-day cycles)