This is an open-label, multicenter study to evaluate safety and tolerability, determine the RP2Ds of tafasitamab alone in Japanese participants with R/R NHL, or to evaluate efficacy and safety of tafasitamab in combination with lenalidomide in Japanese participants with R/R DLBCL, or tafasitimab in combination with lenalidomide plus R-CHOP in Japanese participants with previously untreated DLBC, or tafasitimab in combination with lenalidomide in Japanese participants with previously R/R DLBC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.
parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.
R-CHOP is a combination regimen consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone. R-CHOP will be administered at protocol defined timepoints based on the groups participants are assigned.
Aichi Cancer Center Hospital
Aichi, Japan
Chiba Cancer Center
Chiba, Japan
National Cancer Center Hospital East
Chiba, Japan
University of Fukui Hospital
Fukui, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Japan
Kobe City Medical Center General Hospital
Hyōgo, Japan
Tokai University Hospital
Kanagawa, Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, Japan
Nho Kumamoto Medical Center
Kumamoto-ken, Japan
...and 13 more locations
Part 1,2 and 3 : Treatment Emergent Adverse Events (TEAE'S)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Time frame: Approximately 2 years
Part 4: Objective Response
Best Response of complete/complete metabolic response or partial/partial metabolic response
Time frame: Approximately 27 months
Part 1,2, 3 and 4 : Cmax of tafasitamab
Maximum observed serum concentration.
Time frame: Approximately 27 months
Part 1, 2, 3 and 4: Cmin of tafasitamab
Minimum observed serum concentration over the dose interval.
Time frame: Approximately 27 months
Part 4: Complete Response
Defined as the proportion of participants with Complete Response as determined by an IRC and investigator assessment according to the Lugano criteria
Time frame: Approximately 27 months
Part 4: Duration of Response
Defined as the time from the date of first documented evidence of CR or PR until the first documented disease progression or death from any cause, whichever occurs first, among participants who achieve an objective response as determined by IRC and investigator assessment based on the Lugano criteria for response assessment
Time frame: Approximately 27 months
Part 4: Progression-Free Survival
Defined as the time from the date of randomization until the first documented disease progression as determined by IRC and investigator assessment based on the Lugano criteria for response assessment or death from any cause, whichever occurs first.
Time frame: Approximately 27 months
Part 4: Overall Survival
Defined as the time from the date of randomization until death from any cause.
Time frame: Approximately 27 months
Part 4: Overall Response Rate
Defined as the proportion of participants with a CR or PR as determined by the investigator based on the Lugano criteria for response assessment
Time frame: Approximately 27 months
Part 4: Treatment Emergent Adverse Events (TEAE'S)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Time frame: Approximately 2 years
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