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Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia

Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 (Umbralisib) Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)

NCT02612311•TG Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) participants.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Treatment naïve or previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
•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 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)
•Prior therapy with obinutuzumab and/or chlorambucil or a PI3K delta inhibitor

Locations (154)

TG Therapeutics Investigational Trial Site

Huntsville, Alabama, United States

TG Therapeutics Investigational Trial Site

Mobile, Alabama, United States

TG Therapeutics Investigational Trial Site

Chandler, Arizona, United States

TG Therapeutics Investigational Trial Site

Phoenix, Arizona, United States

TG Therapeutics Investigational Trial Site

Tucson, Arizona, United States

TG Therapeutics Investigational Trial Site

Fayetteville, Arkansas, United States

TG Therapeutics Investigational Trial Site

Concord, California, United States

TG Therapeutics Investigational Trial Site

Duarte, California, United States

TG Therapeutics Investigational Trial Site

Greenbrae, California, United States

TG Therapeutics Investigational Trial Site

Pismo Beach, California, United States

Key Dates

Start Date

November 19, 2015

Primary Completion Date

February 22, 2023

Completion Date

February 22, 2023

Last Updated

December 13, 2024

Enrollment

603

ACTUAL participants

Conditions

Chronic Lymphocytic Leukemia

Interventions

Obinutuzumab

BIOLOGICAL

Ublituximab

BIOLOGICAL

TGR-1202

DRUG

Chlorambucil

DRUG

Sponsors

Lead Sponsor

TG Therapeutics, Inc.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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