Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi

Phase 2 Completed 24 enrolled MorphoSys AG

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a two-cohort, multicenter, open-label study of tafasitamab (MOR208) combined with idelalisib or venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy. Patients completing the study treatment are invited to participate in an optional biomarker sub-study.

Timeline

Start: 2016-11
Primary completion: 2018-11
Completion: 2021-12

Publications

Staber PB, Jurczak W, Greil R, Vucinic V, Middeke JM, Montillo M, Munir T, Neumeister P, Schetelig J, Stilgenbauer S, Striebel F, Dirnberger-Hertweck M, Weirather J, Brugger W, Kelemen P, Wendtner CM, Woyach JA. Tafasitamab combined with idelalisib or venetoclax in patients with CLL previously treated with a BTK inhibitor. Leuk Lymphoma. 2021 Dec;62(14):3440-3451. doi: 10.1080/10428194.2021.1964020. Epub 2021 Aug 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Idelalisib	Small molecule	150 mg	Oral
Subject	Tafasitamab	Monoclonal antibody	12 mg/kg	Intravenous
Subject	Venetoclax	Small molecule	400 mg	Oral

Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi

Summary

Timeline

Publications

Drugs

Indications