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Evaluate the Efficacy and Safety of TGR-1202 in Patients With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy

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ClinicalTrials.gov Identifier: NCT02742090
Recruitment Status : Active, not recruiting
First Posted : April 18, 2016
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
This is a Phase 2, open-label, study of TGR-1202, a PI3K delta inhibitor, administered as a single agent in Chronic Lymphocytic Leukemia (CLL) patients who are intolerant to prior BTK inhibitors (ibrutinib, other) or prior PI3K delta inhibitors (idelalisib, other)

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: TGR-1202 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK (Bruton Tyrosine Kinase) or PI3K-Delta (Phosphoinositide-3-kinase) Inhibitor Therapy
Study Start Date : April 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: TGR-1202
Oral daily dose of TGR-1202
Drug: TGR-1202



Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: From date of enrollment until the date of first documented progression, assessed up through 2 years ]

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
  • Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
  • Presence of measurable disease

Exclusion Criteria:

  • Progression on prior BTK or PI3K delta inhibitor
  • Prior treatment with TGR-1202
  • Richter's transformation or CLL transformation to aggressive lymphoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742090


Locations
United States, District of Columbia
TG Therapeutics Investigational Trial Site
Washington, District of Columbia, United States, 20007
United States, Florida
TG Therapeutics Investigational Trial Site
Fort Myers, Florida, United States, 33916
TG Therapeutics Investigational Trial Site
Saint Petersburg, Florida, United States, 33705
United States, Missouri
TG Therapeutics Investigational Trial Site
Kansas City, Missouri, United States, 64132
United States, New Hampshire
TG Therapeutics Investigational Trial Site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
TG Therapeutics Investigational Trial Site
Hackensack, New Jersey, United States, 07601
United States, New York
TG Therapeutics Investigational Trial Site
New Hyde Park, New York, United States, 11042
TG Therapeutics Investigational Trial Site
New York, New York, United States, 10032
TG Therapeutics Investigational Trial Site
Rochester, New York, United States, 14642
United States, North Carolina
TG Therapeutics Investigational Trial Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
TG Therapeutics Investigational Trial Site
Hershey, Pennsylvania, United States, 17033
TG Therapeutics Investigational Trial Site
Philadelphia, Pennsylvania, United States, 19146
United States, Tennessee
TG Therapeutics Investigational Trial Site
Nashville, Tennessee, United States, 37203
United States, Washington
TG Therapeutics Investigational Trial Site
Seattle, Washington, United States, 98104
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
Study Chair: Anthony Mato, MD University of Pennsylvania Center for CLL

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02742090     History of Changes
Other Study ID Numbers: TGR-1202-201-CLL
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available upon study closure or as the study evolves

Keywords provided by TG Therapeutics, Inc.:
CLL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell