Ofatumumab Added to Dexamethasone in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia

Phase 2 Completed 33 enrolled Brno University Hospital Faculty Hospital Kralovske Vinohrady · collab General Teaching Hospital, Prague · collab University Hospital Hradec Kralove · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The rationale of the study is to explore the safety and efficacy of ofatumumab in combination with dexamethasone (O-dex regimen) in patients with refractory/relapsed CLL. Moreover, the hypothesis is that this approach will be able to achieve at least the same response rates compared with R-dex regimens (historical controls; manuscript submitted to Leukemia), while maintaining lower toxicity profile.

Timeline

Start: 2011-04
Primary completion: 2015-02
Completion: 2015-02

Publications

Doubek M, Brychtova Y, Panovska A, Sebejova L, Stehlikova O, Chovancova J, Malcikova J, Smardova J, Plevova K, Volfova P, Trbusek M, Mraz M, Bakesova D, Trizuljak J, Hadrabova M, Obrtlikova P, Karban J, Smolej L, Oltova A, Jelinkova E, Pospisilova S, Mayer J. Ofatumumab added to dexamethasone in patients with relapsed or refractory chronic lymphocytic leukemia: Results from a phase II study. Am J Hematol. 2015 May;90(5):417-21. doi: 10.1002/ajh.23964. Epub 2015 Apr 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ofatumumab	Monoclonal antibody	1000 mg	Intravenous
Background	Dexamethasone	Small molecule	40 mg	Oral

Ofatumumab Added to Dexamethasone in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia

Summary

Timeline

Publications

Drugs

Indications