Cancer

Title
A Phase 2, Randomized Study Combining Standard RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) Chemotherapy with Brentuximab Vedotin at 2 Different Dose Levels in the Front-line Treatment for Patients with Diffuse Large B-cell Lymphoma (DLBCL)
Trial Number
205397061913
Number of Participants
50
Principal Investigator

Scott Smith

M.D.,Ph.D., FACP
Hematology/Oncology
Associate Professor
Eligibility

Treatment-naive patients with systemic de novo or transformed DLBCL, or follicular NHL grade 3b; patients must have an IPI score =3, and stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB–IV disease. Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and measurable disease of at least 1.5 cm by computed tomography (CT), as assessed by the site radiologist; an Eastern Cooperative Oncology Group (ECOG) performance status =2; age 18 or older; patients must meet baseline laboratory data; females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (ß-hCG) pregnancy test result within seven days prior to the first dose; females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraception method during the study and for 12 months following the last dose of study drug.

Purpose

To find out the good and bad effects of brentuximab vedotin at two different dose levels as a first treatment for diffuse large B-cell lymphoma (DLBCL).

Enrollment

(708) 327-3228

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