A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL

Summary

This research study is evaluating a combination of drugs called Ofatumumab and Idelalisib as a possible treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL). The main purpose of this study is to examine the combination of the two drugs, Ofatumumab and Idelalisib, in participants who have been diagnosed with CLL/SLL and have not previously received treatment but do require treatment. The investigators hope to observe how participants' disease will be impacted by this treatment and whether they will benefit more from combining these drugs together rather than taking them separately. Both of these drugs have been used in treatment for CLL / SLL and information from those research studies suggests that these drugs may help patients with CLL/SLL. Ofatumumab is an antibody engineered in the lab against CD20, a protein on the surface of CLL cells, which is expressed in CLL. An antibody is a molecule your body creates to identify foreign substances so that it can destroy them. Ofatumumab has been FDA approved for treatment of CLL/SLL that has relapsed or progressed on other therapies. Idelalisib is a drug that blocks one of the signals inside the cells that cause this type of cancer to grow and survive. The investigators hope that combining Ofatumumab with Idelalisib will stop the growth of disease. In this research study, the investigators are evaluating the side effects of combining these two drugs, gathering information on the CLL/SLL disease process and how the study affects the patient's cells, as well as assessing the outcome of the disease. This combination of drugs has been previously tested, and appeared to be well tolerated.

Timeline

Start

2014-06

Primary completion

2020-10-06

Completion

2020-10-06

Publications

• Lampson BL, Kim HT, Davids MS, Abramson JS, Freedman AS, Jacobson CA, Armand PA, Joyce RM, Arnason JE, Rassenti LZ, Kipps TJ, Fein J, Fernandes SM, Hanna JR, Fisher DC, Brown JR. Efficacy results of a phase 2 trial of first-line idelalisib plus ofatumumab in chronic lymphocytic leukemia. Blood Adv. 2019 Apr 9;3(7):1167-1174. doi: 10.1182/bloodadvances.2018030221.
• Lampson BL, Kasar SN, Matos TR, Morgan EA, Rassenti L, Davids MS, Fisher DC, Freedman AS, Jacobson CA, Armand P, Abramson JS, Arnason JE, Kipps TJ, Fein J, Fernandes S, Hanna J, Ritz J, Kim HT, Brown JR. Idelalisib given front-line for treatment of chronic lymphocytic leukemia causes frequent immune-mediated hepatotoxicity. Blood. 2016 Jul 14;128(2):195-203. doi: 10.1182/blood-2016-03-707133. Epub 2016 May 31.

Drugs

Indications