Study Comparing Tafasitamab, Lenalidomide, and R-CHOP with R-CHOP Alone in Newly Diagnosed High-Risk DLBCL Patients

Sponsor: Incyte Corporation

Sponsor score: 60

ClinicalTrials ID:NCT04824092

This clinical trial is testing whether adding the drugs tafasitamab and lenalidomide to the standard R-CHOP treatment can improve outcomes for patients newly diagnosed with high-risk diffuse large B-cell lymphoma (DLBCL).

Patient Parameters

Program Overview

This study aims to compare the effectiveness and safety of a new treatment combination for patients with high-risk diffuse large B-cell lymphoma (DLBCL). The trial will test if adding the drugs tafasitamab and lenalidomide to the standard R-CHOP chemotherapy regimen can provide better results than R-CHOP alone. R-CHOP is a common treatment for DLBCL and includes the drugs rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with certain types of diffuse large B-cell lymphoma (DLBCL), confirmed by a biopsy.
  • Must not have received any previous treatment for DLBCL.
  • Must have a specific risk level based on age and other factors.
  • Must start treatment within 28 days of diagnosis.
  • Must be in good general health, with a performance status score of 0, 1, or 2.
  • Must have a heart function of 50% or higher.
  • Must have adequate blood cell counts and organ function.
  • Women must agree to use birth control and undergo regular pregnancy tests.
  • Men must agree to use condoms or remain abstinent during the study.

Exclusion Criteria

  • Have a different type of lymphoma not included in the study.
  • Have had another type of cancer, unless it was treated successfully and has been inactive for over two years.
  • Have received any previous treatment for lymphoma, except for certain allowed pre-treatments.
  • Have any known involvement of the central nervous system (CNS) by lymphoma.
  • Have any active infections or a history of significant heart, brain, or other diseases that could interfere with the study.

Locations

FACILITYZIPCITYSTATE
MorphoSys Research Site36526DaphneAlabama
MorphoSys Research Site92801AnaheimCalifornia
MorphoSys Research Site93611ClovisCalifornia
MorphoSys Research Site92834-4138FullertonCalifornia
MorphoSys Research Site90710Harbor CityCalifornia
MorphoSys Research Site90017Los AngelesCalifornia
MorphoSys Research Site92123San DiegoCalifornia
MorphoSys Research Site90603WhittierCalifornia
MorphoSys Research Site80012AuroraColorado
MorphoSys Research Site32224JacksonvilleFlorida

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