NCT02793583|TerminatedPhase 2

Study Stopped

Strategic/Business Decision

Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

UNITY-NHL

A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma

TG Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

UTX-TGR-205

Study Type

interventional

Target

710

Locations

9 countries

Sites

168

Timeline

RegisteredJun 2016

StartedMay 2016

CompletionJul 2022

Brief Summary

Unity NHL - A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib with or without Bendamustine and Umbralisib alone in Patients with Previously Treated Non-Hodgkin's Lymphoma

Trial Health

Monitor

Trial Health Score

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

Enrollment

710

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started May 2016

Longer than P75 for phase_2

Geographic Reach

9 countries

168 active sites

Status

terminated

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

6.1 years study duration

First Submitted

Initial submission to the registry

May 23, 2016

Completed

2 days until next milestone

Study Start

First participant enrolled

May 25, 2016

Completed

14 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed

6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2022

Completed

Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

6 years

First QC Date

May 23, 2016

Last Update Submit

July 20, 2022

Conditions

Diffuse Large B-Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Mantle Cell Lymphoma Small Lymphocytic Lymphoma

Keywords

DLBCLFLMZLMCLSLLNon-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

Overall Response Rate
Every 8-12 weeks, up to 2 years

Secondary Outcomes (1)

Progression-Free Survival
From date of randomization until the date of first documented progression, assessed up through 2 years

Study Arms (3)

Umbralisib + Ublituximab

EXPERIMENTAL

Umbralisib oral daily dose in combination with Ublituximab intravenous administration

Biological: UblituximabDrug: Umbralisib

Umbralisib

EXPERIMENTAL

Umbralisib oral daily dose

Drug: Umbralisib

Umbralisib + Ublituximab + Bendamustine

EXPERIMENTAL

Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration

Biological: UblituximabDrug: UmbralisibBiological: Bendamustine

Interventions

UblituximabBIOLOGICAL

Also known as: TG-1101

Umbralisib + UblituximabUmbralisib + Ublituximab + Bendamustine

UmbralisibDRUG

Also known as: TGR-1202

UmbralisibUmbralisib + UblituximabUmbralisib + Ublituximab + Bendamustine

BendamustineBIOLOGICAL

Also known as: Treanda

Umbralisib + Ublituximab + Bendamustine

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Diagnosis of Non-Hodgkin's Lymphoma including Follicular, Mantle Cell Lymphoma and Marginal Zone Lymphoma
Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant
MCL subjects with one or more lines of therapy including at least one BTK inhibitor (ibrutinib, acalabrutinib or zanibrutinib only)

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 HIV infection
Autologous hematologic stem cell transplant within 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
Prior therapy with a PI3K delta inhibitor

Contact the study team to confirm eligibility.