NCT02301156|CompletedPhase 3ResultsDMCFDA Drug

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

GENUINE

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)

TG Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

UTX-IB-301

Study Type

interventional

Target

126

Locations

2 countries

Sites

Timeline

RegisteredNov 2014

StartedJan 2015

CompletionApr 2020

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

126

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Jan 2015

Longer than P75 for phase_3

Geographic Reach

2 countries

88 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.2 years study duration

First Submitted

Initial submission to the registry

November 20, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed

2 months until next milestone

Study Start

First participant enrolled

January 27, 2015

Completed

5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed

2.1 years until next milestone

Results Posted

Study results publicly available

May 20, 2022

Completed

Last Updated

May 20, 2022

Status Verified

April 1, 2022

Enrollment Period

5.2 years

First QC Date

November 20, 2014

Results QC Date

April 25, 2022

Last Update Submit

April 25, 2022

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

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.
Up to 62 months

Secondary Outcomes (6)

Complete Response (CR) Rate
Up to 62 months
Minimum Residual Disease (MRD) Negativity Rate
Up to 62 months
Progression-Free Survival (PFS)
From the randomization until the first documentation of PD or death whichever occurs first or up to 62 months
Duration of Response (DOR)
From the first dose of study drug until the first documentation of PD or death whichever occurs first or up to 62 months
Time to Response (TTR)
From the randomization up to 62 months
+1 more secondary outcomes

Study Arms (2)

Ublituximab + Ibrutinib

EXPERIMENTAL

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.

Drug: UblituximabDrug: Ibrutinib

Ibrutinib

ACTIVE COMPARATOR

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

Drug: Ibrutinib

Interventions

UblituximabDRUG

Administered as an IV infusion

Also known as: TG-1101

Ublituximab + Ibrutinib

IbrutinibDRUG

Administered orally

Also known as: IMBRUVICA

IbrutinibUblituximab + Ibrutinib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.