To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

Sponsor
Incyte Biosciences Japan GK
Study ID
NCT04661007
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tafasitamab — DRUG
    tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
  • lenalidomide — DRUG
    lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.
  • parsaclisib — DRUG
    parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.
  • R-CHOP — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 15, 2020
Status verified
May 2026
Primary completion
Jul 1, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
72 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 : tafasitimab monotherapy
    Dose-finding to evaluate the safety and tolerability and to determine the RP2Ds of single-agent tafasitamab in Japanese participants with NHL. Part 1 consists of 1 group (Group 1) to evaluate weight-based doses of tafasitamab.
  • Experimental: Part 2 : tafasitamab combination therapy
    tafasitamab will be combined with lenalidomide (Group 3) or parsaclisib (Group 4a) in R/R DLBCL participants or lenalidomide plus R-CHOP (Group 5) in previously untreated DLBCL participants. Modified tafasitamab dosing when combined with lenalidomide (Group 2) in participants with R/R DLBCL will be evaluated to determine the recommended clinical dose. The dose of tafasitamab will be based on the weight-based RP2D that is deemed safe and tolerable in Part 1.
  • Experimental: Part 3 : Dose Expansion of tafasitamab +parsaclisib
    tafasitamab in combination with parsaclisib will be further evaluated in Group 4b at RP2D determined in Part 2
  • Experimental: Part 4: tafasitamab combination therapy
    tafasitamiab in combination with lenalidomide will be further evaluated in Group 6 at RP2D determined in Part 2.

Primary Outcome Measure

Part 1,2 and 3 : Treatment Emergent Adverse Events (TEAE'S) [ Time Frame: Approximately 2 years ]

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