search
Back to results

Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL) (GENUINE)

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ublituximab
Ibrutinib
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:

  • Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
  • At least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection
  • Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
  • Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
  • Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK)

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
  • TG Therapeutics Investigational Trial Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ublituximab + Ibrutinib

Ibrutinib

Arm Description

Participants will receive ublituximab intravenous (IV) infusion, up to 150 milligrams (mg) once on Day 1, 750 mg on Day 2, 900 mg on Days 8 and 15 of Cycle 1 (Cycle duration=28 days) followed by 900 mg on Day 1 of Cycles 2 to 6 and 900 mg on Day 1 of every 3rd cycle thereafter for up to 62 months along with ibrutinib 420 mg capsules, orally, once daily (QD) in each 28-day cycle for up to 62 months.

Participants will receive ibrutinib 420 mg capsules, orally, QD in each 28-day cycle up to 62 months.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
ORR: Percentage of participants with best overall response of partial response(PR) and complete response(CR). CR criteria: 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 criteria: 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.

Secondary Outcome Measures

Complete Response (CR) Rate
The CR rate was defined as the percentage of participants who achieved CR. CR criteria: 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.
Minimum Residual Disease (MRD) Negativity Rate
MRD negativity rate was defined as the percentage of participants who were MRD negative post-baseline. 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.
Progression-Free Survival (PFS)
PFS was defined as the time from the date of randomization until the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first. PD requires at least one of the following: 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 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.
Time to Response (TTR)
TTR was defined as the interval from the randomization to the first documentation of CR or PR. CR criteria: 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. PR criteria: No evidence of new disease; Response in 2 of following when abnormal at baseline: ALC<4 x 10^9/L or >=50% decrease from baseline in SPD of target nodal lesions; splenomegaly; hepatomegaly; >=50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules; and Response in 1 of the following: ANC>1.5 x 10^9/L, platelets>100 x 10^9/L, Hgb>110 g/L or >=50% increase over baseline in any of these.
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is 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
November 20, 2014
Last Updated
April 25, 2022
Sponsor
TG Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02301156
Brief Title
Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Acronym
GENUINE
Official Title
A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 27, 2015 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR [complete response] + PR [partial response]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.

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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ublituximab + Ibrutinib
Arm Type
Experimental
Arm Description
Participants will receive ublituximab intravenous (IV) infusion, up to 150 milligrams (mg) once on Day 1, 750 mg on Day 2, 900 mg on Days 8 and 15 of Cycle 1 (Cycle duration=28 days) followed by 900 mg on Day 1 of Cycles 2 to 6 and 900 mg on Day 1 of every 3rd cycle thereafter for up to 62 months along with ibrutinib 420 mg capsules, orally, once daily (QD) in each 28-day cycle for up to 62 months.
Arm Title
Ibrutinib
Arm Type
Active Comparator
Arm Description
Participants will receive ibrutinib 420 mg capsules, orally, QD in each 28-day cycle up to 62 months.
Intervention Type
Drug
Intervention Name(s)
Ublituximab
Other Intervention Name(s)
TG-1101
Intervention Description
Administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
IMBRUVICA
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR: Percentage of participants with best overall response of partial response(PR) and complete response(CR). CR criteria: 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 criteria: 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 62 months
Secondary Outcome Measure Information:
Title
Complete Response (CR) Rate
Description
The CR rate was defined as the percentage of participants who achieved CR. CR criteria: 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 62 months
Title
Minimum Residual Disease (MRD) Negativity Rate
Description
MRD negativity rate was defined as the percentage of participants who were MRD negative post-baseline. 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
Up to 62 months
Title
Progression-Free Survival (PFS)
Description
PFS was defined as the time from the date of randomization until the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first. PD requires at least one of the following: 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 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
From the randomization until the first documentation of PD or death whichever occurs first or up to 62 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
From the first dose of study drug until the first documentation of PD or death whichever occurs first or up to 62 months
Title
Time to Response (TTR)
Description
TTR was defined as the interval from the randomization to the first documentation of CR or PR. CR criteria: 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. PR criteria: No evidence of new disease; Response in 2 of following when abnormal at baseline: ALC<4 x 10^9/L or >=50% decrease from baseline in SPD of target nodal lesions; splenomegaly; hepatomegaly; >=50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules; and Response in 1 of the following: ANC>1.5 x 10^9/L, platelets>100 x 10^9/L, Hgb>110 g/L or >=50% increase over baseline in any of these.
Time Frame
From the randomization up to 62 months
Title
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
Description
An adverse event (AE) is 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
From the first dose up to 30 days after the last dose of study drug (up to 57.3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment At least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: Any major surgery, chemotherapy or immunotherapy within the last 21 days Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation) Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Sharman, MD
Organizational Affiliation
Willamette Valley Cancer Institute
Official's Role
Study Chair
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
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
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
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
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
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
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
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
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
19173
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
33905
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
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
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
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
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70816
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
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
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
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
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
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
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Howell
State/Province
New Jersey
ZIP/Postal Code
07731
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Pompton Plains
State/Province
New Jersey
ZIP/Postal Code
07444
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10019
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
27710
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
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
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2982
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
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
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
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
29607
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
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
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
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
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Denton
State/Province
Texas
ZIP/Postal Code
76201
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598-4420
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
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
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
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
Vancouver
State/Province
Washington
ZIP/Postal Code
98683
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Ashkelon
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
TG Therapeutics does not currently plan to share IPD.
Citations:
PubMed Identifier
33631112
Citation
Sharman JP, Brander DM, Mato AR, Ghosh N, Schuster SJ, Kambhampati S, Burke JM, Lansigan F, Schreeder MT, Lunin SD, Zweibach A, Shtivelband M, Travis PM, Chandler JC, Kolibaba KS, Sportelli P, Miskin HP, Weiss MS, Flinn IW. Ublituximab plus ibrutinib versus ibrutinib alone for patients with relapsed or refractory high-risk chronic lymphocytic leukaemia (GENUINE): a phase 3, multicentre, open-label, randomised trial. Lancet Haematol. 2021 Apr;8(4):e254-e266. doi: 10.1016/S2352-3026(20)30433-6. Epub 2021 Feb 22. Erratum In: Lancet Haematol. 2021 Apr;8(4):e249.
Results Reference
derived

Learn more about this trial

Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

We'll reach out to this number within 24 hrs