West Cancer Center

LEUKEMIA: CLL; Phase 1; PI3K inhibitor; "TGR-GA-106"

A multi-center phase I/Ib study evaluating the efficacy and safety of TGR-1202, a novel PI3K delta inhibitor, in combination with obinutuzumab and chlorambucil in patients with chronic lymphocytic leukemia

Title

TG Therapeutics TGR-GA-106

Study Title

Site Link

NCT02100852

Malignancy

Leukemia, CLL, SLL, chronic lymphocytic leukemia, small lymphocytic lymphoma

Stage

N/A

Disease Setting

Any CLL

Line Of Therapy

Any

Investigational Agent

TGR-1202

Drug Class

PI3K inhibitor

Daruka Mahadevan, MD, PhD

Sponsor

TG Therapeutics

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02100852

Key Eligibility Criteria Details

Confirmed CLL
ECOG 0-2
No intracranial involvement orprimary CNS lymphoma
No auto HCT within 3 months of entry
No allo HCT within 12 months

Objective

Primary- MTD; Secondary- ORR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

CLL

Dosing Frequency

TGR-1202- oral given daily; obinutuzumab- IV; chlorambucil- oral on specified days

Control Agents

Obinutuzumab, Chlorambucil

Study Protocol

Randomized