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Nearly 19,000 new cases of chronic lymphocytic leukemia (CLL) will be reported this year in the U.S., according to American Cancer Society statistics.

Testing new drugs

Sinai Hospital and Northwest Hospital, members of LifeBridge Health, are participating in two nationwide clinical trials sponsored by TG Therapeutics aimed at improving treatment options for people with CLL. TG Therapeutics is a biopharmaceutical company currently developing therapies that target cancers that begin in the cells of blood-forming tissue (bone marrow).

Both studies are Phase 3 trials, meaning the drugs being studied have already been through two previous phases of testing.

One trial is called the Genuine Trial. It has two arms: The first is the experimental arm, which will assess the efficacy and safety of the drug Ublituximab, a monoclonal antibody that is not yet approved for use by the FDA, in combination with the drug Ibrutinib, which is approved. In the other arm, participants will take Ibrutinib alone.

This study is aimed at participants who have been previously treated for CLL, and have the presence of high-risk features as identified by cellular abnormalities.

Patients taking both drugs will receive three separate intravenous infusions of Ublituximab followed by maintenance infusions and an oral daily dose of Ibrutinib. Patients in the second arm will receive an oral daily dose of Ibrutinib.

The other trial, called the Unity Trial, will assess the efficacy and safety of Ublituximab used in combination with another drug for which approval is being sought — TGR-1202. A second arm of this study compares that combination to the use of the drug Obinutuzumab in combination with Chlorambucil. Both of these drugs are already approved and in use for treatment of CLL.

The Unity Trial is for CLL patients without high-risk features, and who either have not had treatment before or need recurrent treatment.

Patients in the first arm of this trial will receive three separate intravenous infusions of Ublituximab, followed by maintenance infusions and an oral daily dose of TGR-1202. Patients in the second arm will receive eight intravenous infusions of Obinutuzumab and scheduled oral doses of Chlorambucil.

Open-ended study

Treatments will take place at either Northwest Hospital or Sinai Hospital. Participants do not have to be current LifeBridge Health patients.

Participants will continue in the trial until the doctor no longer feels they are receiving any benefit from it. There is no financial compensation for participation.

Researchers intend to assess the survival rate of patients treated in both trials over the course of three years. The Genuine Trial is recruiting 330 participants; the Unity Trial, 450.

To learn more about these studies, or to see if you qualify to participate, visit www.ClinicalTrials.gov and search for the following trial numbers: NCT02301156 and NCT02612311. You may also call the Oncology Research Office at Sinai Hospital at (410) 601-6120.