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A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ublituximab
Umbralisib
Sponsored by
TG Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Prior treatment in clinical trial UTX-TGR-304
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Patients refractory to ublituximab + TGR-1202
  • Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)

Sites / Locations

  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Parent Study Arm B

Parent Study Arm C

Parent Study Arm D

Arm Description

Participants from Arm B of the parent trial (UTX-TGR-304) received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.

Participants from Arm C of the parent trial (UTX-TGR-304) received ublituximab, 900 mg, IV, on Day 1 of Cycles 1-6 (cycle length=28 days), and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.

Participants from Arm D of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR) as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria
ORR was defined as sum of participants with partial responses (PR) and complete responses (CR). CR: No evidence of new disease; Absolute lymphocyte count(ALC)<4x10^9/liter(L); Regression of all target nodal masses to ≤1.5 centimeters (cm) in longest diameter(LD); Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; Absolute neutrophil count(ANC)>1.5x10^9/L,platelets≥100x10^9/L,hemoglobin (Hgb)≥110 gram per liter(g/L). PR: No evidence of new disease; Response in 2 of following if abnormal at baseline: ALC<4x10^9/L or ≥50% decrease from baseline in sum of products(SPD) of target nodal lesions; splenomegaly; hepatomegaly;≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules; response in any 1:ANC>1.5x10^9/L,platelets>100x10^9/L,Hgb>110g/L or ≥50% increase over baseline in any of these.
Complete Response (CR) Rate Per iwCLL Criteria
The CR rate was defined as the percentage of participants who achieved CR. CR: No evidence of new disease; ALC <4 x 10^9/L; Regression of all target nodal masses to normal size ≤1.5 cm in the LD; Normal spleen and liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; ANC >1.5 x 10^9/L, platelets ≥100 x 10^9/L, Hgb ≥110 g/L.
Progression-Free Survival (PFS) Per iwCLL Criteria
PFS was defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. PD was appearance of new nodes >1.5 cm in the LD and >1.0 in longest perpendicular diameter (LPD), new or recurrent hepatomegaly or splenomegaly, new or reappearance of an unequivocal extra-nodal lesion, ≥50% increase from the nadir in the sum of products of diameters (SPD) of target lesions, ≥50% increase in the LD of an individual node or extra-nodal mass, splenic/hepatic enlargement of ≥50% from nadir, unequivocal increase in the size of non-target disease, transformation to a more aggressive histology, decrease in platelet count or Hgb, >50% decrease from the highest on-study platelet count, >20 g/L decrease from the highest on-study Hgb.
Duration of Response (DOR)
DOR:Interval from first documentation of CR/PR to first documentation of PD or death from any cause.CR:ALC<4x10^9/L;Regression to normal of target nodal masses,nodal non-target disease,and no detectable non-nodal,non-target disease;Normal spleen,liver size;Morphologically negative bone marrow,No lymphoid nodules;ANC>1.5x10^9/L,Platelets≥100x10^9/L,Hgb≥110 g/L.PR:Response in 2 or more:ALC<4x10^9/L, ≥50% drop from baseline in ALC or SPD of target nodal lesions,Hepatosplenomegaly,≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules;Response in 1 or more:ANC>1.5x10^9/L,Platelets>100x10^9/L,Hgb>110 g/L or ≥50% increase over baseline in any.PD:Response in 1 or more:new nodes,Hepatosplenomegaly,unequivocal extra-nodal lesion;≥50% increase from nadir in SPD of target lesions or LD of node/extra-nodal mass or Splenic/Hepatic size,Unequivocal increase in non-target disease,More aggressive histology;Drop of >50% in platelets/>20g/L in Hgb from highest on-study count.

Secondary Outcome Measures

Minimal Residual Disease (MRD) Negativity Rate
MRD negativity rate is defined as the percentage of participants who are MRD negative. If a participant was determined to be MRD negative by peripheral blood, a bone marrow aspirate was obtained to assess MRD in the bone marrow.
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related.

Full Information

First Posted
January 13, 2016
Last Updated
May 26, 2023
Sponsor
TG Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02656303
Brief Title
A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304
Official Title
A Multi-Center, Open-Label, Compassionate Use Extension Study of Ublituximab (TG-1101) in Combination With Umbralisib (TGR-1202) for Patients Previously Enrolled in Protocol UTX-TGR-304
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Strategic/Business Decision
Study Start Date
January 7, 2016 (Actual)
Primary Completion Date
May 26, 2022 (Actual)
Study Completion Date
July 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to provide the opportunity to the participants who progressed on treatment arm previously in the study UTX-TGR-304 (NCT02612311) to receive ublituximab (TG-1101) treatment in combination with umbralisib (TGR-1202).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent Study Arm B
Arm Type
Experimental
Arm Description
Participants from Arm B of the parent trial (UTX-TGR-304) received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Arm Title
Parent Study Arm C
Arm Type
Experimental
Arm Description
Participants from Arm C of the parent trial (UTX-TGR-304) received ublituximab, 900 mg, IV, on Day 1 of Cycles 1-6 (cycle length=28 days), and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Arm Title
Parent Study Arm D
Arm Type
Experimental
Arm Description
Participants from Arm D of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Intervention Type
Biological
Intervention Name(s)
Ublituximab
Other Intervention Name(s)
TG-1101
Intervention Description
Ublituximab IV infusion
Intervention Type
Drug
Intervention Name(s)
Umbralisib
Other Intervention Name(s)
TGR-1202
Intervention Description
Umbralisib tablets
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria
Description
ORR was defined as sum of participants with partial responses (PR) and complete responses (CR). CR: No evidence of new disease; Absolute lymphocyte count(ALC)<4x10^9/liter(L); Regression of all target nodal masses to ≤1.5 centimeters (cm) in longest diameter(LD); Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; Absolute neutrophil count(ANC)>1.5x10^9/L,platelets≥100x10^9/L,hemoglobin (Hgb)≥110 gram per liter(g/L). PR: No evidence of new disease; Response in 2 of following if abnormal at baseline: ALC<4x10^9/L or ≥50% decrease from baseline in sum of products(SPD) of target nodal lesions; splenomegaly; hepatomegaly;≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules; response in any 1:ANC>1.5x10^9/L,platelets>100x10^9/L,Hgb>110g/L or ≥50% increase over baseline in any of these.
Time Frame
Up to 76 months
Title
Complete Response (CR) Rate Per iwCLL Criteria
Description
The CR rate was defined as the percentage of participants who achieved CR. CR: No evidence of new disease; ALC <4 x 10^9/L; Regression of all target nodal masses to normal size ≤1.5 cm in the LD; Normal spleen and liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; ANC >1.5 x 10^9/L, platelets ≥100 x 10^9/L, Hgb ≥110 g/L.
Time Frame
Up to 76 months
Title
Progression-Free Survival (PFS) Per iwCLL Criteria
Description
PFS was defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. PD was appearance of new nodes >1.5 cm in the LD and >1.0 in longest perpendicular diameter (LPD), new or recurrent hepatomegaly or splenomegaly, new or reappearance of an unequivocal extra-nodal lesion, ≥50% increase from the nadir in the sum of products of diameters (SPD) of target lesions, ≥50% increase in the LD of an individual node or extra-nodal mass, splenic/hepatic enlargement of ≥50% from nadir, unequivocal increase in the size of non-target disease, transformation to a more aggressive histology, decrease in platelet count or Hgb, >50% decrease from the highest on-study platelet count, >20 g/L decrease from the highest on-study Hgb.
Time Frame
Up to 76 months
Title
Duration of Response (DOR)
Description
DOR:Interval from first documentation of CR/PR to first documentation of PD or death from any cause.CR:ALC<4x10^9/L;Regression to normal of target nodal masses,nodal non-target disease,and no detectable non-nodal,non-target disease;Normal spleen,liver size;Morphologically negative bone marrow,No lymphoid nodules;ANC>1.5x10^9/L,Platelets≥100x10^9/L,Hgb≥110 g/L.PR:Response in 2 or more:ALC<4x10^9/L, ≥50% drop from baseline in ALC or SPD of target nodal lesions,Hepatosplenomegaly,≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules;Response in 1 or more:ANC>1.5x10^9/L,Platelets>100x10^9/L,Hgb>110 g/L or ≥50% increase over baseline in any.PD:Response in 1 or more:new nodes,Hepatosplenomegaly,unequivocal extra-nodal lesion;≥50% increase from nadir in SPD of target lesions or LD of node/extra-nodal mass or Splenic/Hepatic size,Unequivocal increase in non-target disease,More aggressive histology;Drop of >50% in platelets/>20g/L in Hgb from highest on-study count.
Time Frame
Up to 76 months
Secondary Outcome Measure Information:
Title
Minimal Residual Disease (MRD) Negativity Rate
Description
MRD negativity rate is defined as the percentage of participants who are MRD negative. If a participant was determined to be MRD negative by peripheral blood, a bone marrow aspirate was obtained to assess MRD in the bone marrow.
Time Frame
From Cycle 6 until Cycle 15 (cycle length=28 days) (Up to approximately 76 months)
Title
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
Description
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related.
Time Frame
Up to 78 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prior treatment in clinical trial UTX-TGR-304 Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: Participants refractory to ublituximab + TGR-1202 Transformation of chronic lymphocytic leukemia (CLL) to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Swansea
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Washington
State/Province
North Carolina
ZIP/Postal Code
27889
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
98684
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Ferrara
ZIP/Postal Code
44020
Country
Italy
Facility Name
TG Therapeutics Investigational Trial Site
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
TG Therapeutics Investigational Trial Site
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
TG Therapeutics Investigational Trial Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
TG Therapeutics Investigational Trial Site
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Słupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Warszawa
ZIP/Postal Code
50-367
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
London
ZIP/Postal Code
SW170QT
Country
United Kingdom
Facility Name
TG Therapeutics Investigational Trial Site
City
Norwich
ZIP/Postal Code
NR47UY
Country
United Kingdom
Facility Name
TG Therapeutics Investigational Trial Site
City
Sunderland
ZIP/Postal Code
SR47TP
Country
United Kingdom
Facility Name
TG Therapeutics Investigational Trial Site
City
Wolverhampton
ZIP/Postal Code
WV100QP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304

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