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

Sponsored by TG Therapeutics, Inc.

About this trial

Last updated 6 years ago

Study ID

TGR-GA-106

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial 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.

What are the participation requirements?

Yes

Inclusion Criteria

- Confirmed Chronic Lymphocytic Leukemia (CLL)

- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

- Ability to swallow oral medication

No

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