Trials / Active Not Recruiting
Active Not RecruitingNCT04661007
To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)
A Phase 1b/2 Study of Tafasitamab, Tafasitamab Plus Lenalidomide, Tafasitamab Plus Parsaclisib, and Tafasitamab Plus Lenalidomide in Combination With R-CHOP in Japanese Participants With Non-Hodgkin Lymphoma
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Incyte Biosciences Japan GK · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tafasitamab | tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned. |
| DRUG | lenalidomide | lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned. |
| DRUG | parsaclisib | parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned. |
| DRUG | R-CHOP | 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. |
Timeline
- Start date
- 2020-12-15
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2020-12-09
- Last updated
- 2025-12-18
Locations
23 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04661007. Inclusion in this directory is not an endorsement.