Overview

This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Treatment tgr-1202 + obinutuzumab + chlorambucil
Phase phase 1
Targets PI3K, CD20
Sponsor TG Therapeutics, Inc.
Start date March 2014
End date March 2017
Trial size 30 participants
Trial identifier NCT02100852, TGR-GA-106

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days.
tgr-1202 + obinutuzumab + chlorambucil Obinutuzumab: Gazyva
TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose

Primary Outcomes

Measure
Maximum Tolerated Dose acceptable for participants
time frame: 28 days (1 cycle of therapy)

Secondary Outcomes

Measure
Overall Response Rate
time frame: Up to 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by TG Therapeutics, Inc..