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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) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

NCT04661007•Incyte Biosciences Japan GK

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Group 1 only: Biopsy-proven participants with relapsed or refractory NHL of DLBCL, FL or MZL.
•Groups 3, 4a and 5 only: Biopsy-proven participants with relapsed or refractory DLBCL.
•Groups 2 and 6 only: Biopsy-proven participants with DLBCL and another select lymphoid neoplasms.
•Participants must have at least 1 bi-dimensionally measurable lesion.
•ECOG performance status of 0 to 2.
•Participants with protocol defined laboratory criteria at screening as defined in the protocol.
•Group 1 only:
•Received at least 1 previous systemic therapy line for the treatment of NHL. At least 1 previous therapy line must have included a CD20-targeted therapy (eg, RTX).
•Groups 2, 3, 4a and 6 only:
•Received at least 1, but no more than 3, previous systemic therapy lines for the treatment of DLBCL. At least 1 previous therapy line must have included a CD20-targeted therapy (eg, RTX).
+10 more criteria

Exclusion Criteria

•Any other histological type of lymphoma.
•History of prior non-hematologic malignancy.
•Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
•Participants with known positive test result for hepatitis C, and hepatitis B.
•Known seropositive for or history of active viral infection with HIV.
•Known active bacterial, viral, fungal, mycobacterial, or other infection at screening.
•Known CNS lymphoma involvement - present or past medical history.
•History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the participant's ability to give informed consent.
•History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
•History or evidence of interstitial lung disease.
+23 more criteria

Locations (23)

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

Key Dates

Start Date

December 15, 2020

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

December 18, 2025

Enrollment

ACTUAL participants

Conditions

Non Hodgkins LymphomaDiffuse Large B-cell Lymphoma

Interventions

tafasitamab

DRUG

lenalidomide

DRUG

parsaclisib

DRUG

R-CHOP

DRUG

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

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RECRUITINGPHASE3

A Long-term Extension Study of PCI-32765 (Ibrutinib)

NCT01804686

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

Long-term Follow up Local Registry Study of Kymriah in South Korea

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms