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

Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: TGR-1202 + Obinutuzumab + Chlorambucil

• Registration Number: NCT02100852
• Lead Sponsor: TG Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-12
• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-01
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TGR-1202 + Obinutuzumab + Chlorambucil	TGR-1202 + Obinutuzumab + Chlorambucil	TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

TG Therapeutics Investigational Trial Site; 🇺🇸 Memphis, Tennessee, United States