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

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02742090
Collaborator
(none)
51
Enrollment
15
Locations
1
Arm
61.6
Actual Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
N/A
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
Actual Study Start Date :
Apr 21, 2016
Actual Primary Completion Date :
Jun 10, 2021
Actual Study Completion Date :
Jun 10, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: TGR-1202

Oral daily dose of TGR-1202

Drug: TGR-1202

Outcome Measures

Primary Outcome Measures

  1. Progression-free Survival [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 [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1TG Therapeutics Investigational Trial SiteHuntsvilleAlabamaUnited States35805
2TG Therapeutics Investigational Trial SiteWashingtonDistrict of ColumbiaUnited States20007
3TG Therapeutics Investigational Trial SiteFort MyersFloridaUnited States33916
4TG Therapeutics Investigational Trial SiteSaint PetersburgFloridaUnited States33705
5TG Therapeutics Investigational Trial SiteKansas CityMissouriUnited States64132
6TG Therapeutics Investigational Trial SiteLebanonNew HampshireUnited States03756
7TG Therapeutics Investigational Trial SiteHackensackNew JerseyUnited States07601
8TG Therapeutics Investigational Trial SiteNew Hyde ParkNew YorkUnited States11042
9TG Therapeutics Investigational Trial SiteNew YorkNew YorkUnited States10032
10TG Therapeutics Investigational Trial SiteRochesterNew YorkUnited States14642
11TG Therapeutics Investigational Trial SiteDurhamNorth CarolinaUnited States27710
12TG Therapeutics Investigational Trial SiteHersheyPennsylvaniaUnited States17033
13TG Therapeutics Investigational Trial SitePhiladelphiaPennsylvaniaUnited States19146
14TG Therapeutics Investigational Trial SiteNashvilleTennesseeUnited States37203
15TG Therapeutics Investigational Trial SiteSeattleWashingtonUnited States98104

Sponsors and Collaborators

  • TG Therapeutics, Inc.

Investigators

  • Study Chair: Anthony Mato, MD, University of Pennsylvania Center for CLL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02742090
Other Study ID Numbers:
  • TGR-1202-201-CLL
First Posted:
Apr 18, 2016
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by TG Therapeutics, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021