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

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 (CLL)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02100852

Enrollment

Registered

2014-04-01

Start date

2014-03-12

Completion date

2017-11-30

Last updated

2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Brief summary

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.

Interventions

DRUGTGR-1202 + Obinutuzumab + Chlorambucil

TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Maximum Tolerated Dose acceptable for participants	28 days (1 cycle of therapy)	To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary

Measure	Time frame	Description
Overall Response Rate	Up to 1 year	To assess the overall response rate (ORR) in patients with chronic lymphocytic leukemia treated with TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026