TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)

TG Therapeutics

Status and phase: Completed; Phase 1

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: TGR-1202 + Obinutuzumab + Chlorambucil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02100852

TGR-GA-106

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic leukemia.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed Chronic Lymphocytic Leukemia (CLL)
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
• Ability to swallow oral medication

Exclusion criteria

• Known hepatitis B virus, hepatitis C virus or HIV infection
• Primary central nervous system lymphoma or known intracranial involvement
• Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

TGR-1202 + Obinutuzumab + Chlorambucil

Experimental group

Description:

TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days.

Treatment:

Drug: TGR-1202 + Obinutuzumab + Chlorambucil