Study Comparing Tafasitamab, Lenalidomide, and R-CHOP with R-CHOP Alone in Newly Diagnosed High-Risk DLBCL Patients
Sponsor: Incyte Corporation
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
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MorphoSys Research Site | 36526 | Daphne | Alabama |
| MorphoSys Research Site | 92801 | Anaheim | California |
| MorphoSys Research Site | 93611 | Clovis | California |
| MorphoSys Research Site | 92834-4138 | Fullerton | California |
| MorphoSys Research Site | 90710 | Harbor City | California |
| MorphoSys Research Site | 90017 | Los Angeles | California |
| MorphoSys Research Site | 92123 | San Diego | California |
| MorphoSys Research Site | 90603 | Whittier | California |
| MorphoSys Research Site | 80012 | Aurora | Colorado |
| MorphoSys Research Site | 32224 | Jacksonville | Florida |
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