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

Information source: TG Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Lymphocytic Leukemia

Intervention: TGR-1202 + Obinutuzumab + Chlorambucil (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: TG Therapeutics, Inc.

Overall contact:
TG Therapeutics Clinical Support Team, Phone: 212-554-4484, Email: clinicalsupport@tgtxinc.com

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.

Clinical Details

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)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose acceptable for participants

Secondary outcome: Overall Response Rate

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

TG Therapeutics Clinical Support Team, Phone: 212-554-4484, Email: clinicalsupport@tgtxinc.com

TG Therapeutics Investigational Trial Site, Huntsville, Alabama 35805, United States; Recruiting

TG Therapeutics Investigational Trial Site, Memphis, Tennessee 38119, United States; Recruiting

Additional Information

Starting date: March 2014
Last updated: March 1, 2015

Page last updated: August 23, 2015

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