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NCT02100852 Clinical Trial

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

Chronic Lymphocytic Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02100852
Other study ID # TGR-GA-106
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 12, 2014
Est. completion date November 2017

Study information
Verified date October 2019
Source TG Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• TGR-1202 + Obinutuzumab + Chlorambucil
TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose

Locations
Country Name City State
United States TG Therapeutics Investigational Trial Site Huntsville Alabama
United States TG Therapeutics Investigational Trial Site Memphis Tennessee

Sponsors (1)
Lead Sponsor Collaborator
TG Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose acceptable for participants To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities 28 days (1 cycle of therapy)
Secondary Overall Response Rate To assess the overall response rate (ORR) in patients with chronic lymphocytic leukemia treated with TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil Up to 1 year
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