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

Sponsor

TG Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02100852

Collaborator

(none)

Enrollment

Locations

Arm

43.7

Actual Duration (Months)

9.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: TGR-1202 + Obinutuzumab + Chlorambucil	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Mar 12, 2014

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: TGR-1202 + Obinutuzumab + Chlorambucil TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose Other Names: Obinutuzumab: Gazyva Chlorambucil: Leukeran

Arm

Intervention/Treatment

Experimental: 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.

Drug: TGR-1202 + Obinutuzumab + Chlorambucil

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

Other Names:

Obinutuzumab: Gazyva

Chlorambucil: Leukeran

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TG Therapeutics Investigational Trial Site	Huntsville	Alabama	United States	35805
2	TG Therapeutics Investigational Trial Site	Memphis	Tennessee	United States	38119