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

NCT04661007 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-05-18

No results posted yet for this study

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

  • Non Hodgkins Lymphoma
  • Diffuse Large B-cell Lymphoma

Interventions

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.

Sponsors & Collaborators

  • Incyte Biosciences Japan GK

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2025-07-01
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04661007 on ClinicalTrials.gov