Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

TG Therapeutics

Status and phase: Completed; Phase 1

Conditions: Chronic Lymphocytic Leukemia; Richter Syndrome

Treatments: Drug: Umbralisib; Biological: ublituximab; Biological: TG-1501

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02535286

TG-UPCC-108

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
• 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 14 days
• Known hepatitis B virus, hepatitis C virus or HIV infection
• Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

TG-1501 + Ublituximab + Umbralisib

Experimental group

Description:

Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals

Treatment:

Biological: TG-1501

Biological: ublituximab

Drug: Umbralisib