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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TG Therapeutics Investigational Trial Site, Huntsville, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TGR-1202 + Obinutuzumab + Chlorambucil

Drug

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

Other names: Obinutuzumab: Gazyva, Chlorambucil: Leukeran

Primary outcomes

Maximum Tolerated Dose acceptable for participants

Time frame: 28 days (1 cycle of therapy)

To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary outcomes

Overall Response Rate

Time frame: 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

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Apr 1, 2014
Registry last updated: Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed