Venetoclax in Combination With Ublituximab and Umbralisib (TGR-1202) in Patients With Relapsed or Refractory CLL / SLL

This study will be a standard 3+3 design with a lead in of umbralisib (TGR-1202) + ublituximab for 12 weeks, i.e. 3 cycles, followed by venetoclax (20 mg - 200 mg) along with umbralisib (TGR-1202) and ublituximab for patients with relapsed / refractory CLL.

Inclusion Criteria

• Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia
• Refractory to or relapsed after at least 1 prior treatment regimen
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria

• Any major surgery, chemotherapy or immunotherapy within the last 21 days
• Known hepatitis B virus, hepatitis C virus or HIV infection
• Known histological transformation from CLL to an aggressive lymphoma (Richter's)

Lead Organization
TG Therapeutics Inc

Primary ID U2-VEN-109
Secondary IDs NCI-2018-01293
Clinicaltrials.gov ID NCT03379051