Clinical Study

Sgn35-031 A Randomized, Double-Blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study Of Brentuximab Vedotin Or Placebo In Combination With Lenalidomide And Rituximab In Subjects With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma

Posted Date: May 24, 2021

  • Investigator: Tahir Latif
  • Specialties: Cancer, Lymphoma, Oncology
  • Type of Study: Drug

Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The primary objective of this study is to study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone. Efficacy will be determined by measuring PFS per blinded independent central review (BICR) in the ITT population and PFS per BICR in the CD30-positive population.


Participants With Relapsed Or Refractory Diffuse And Transformed Large B-Cell Lymphoma (R/R Dlbcl), Participants Must Have R/R Disease Following 2 Or More Lines Of Prior Systemic Therapy, Participants Will Need To Have A Formalin-Fixed Paraffin-Embedded Tumor Tissue (Obtained =4 Weeks Before Day 1) Submitted To The Central Pathology Lab, Ecog Score Of 0 To 2. No History Of Another Malignancy Within 2 Years Before The First Dose Of Study Drug Or Any Evidence Of Residual Disease From A Previously Diagnosed Malignancy, No Active Cerebral/Meningeal Disease Related To The Underlying Malignancy



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Uc Cancer Center

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