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

NCT02612311 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 603

Last updated 2024-12-13

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Obinutuzumab

Obinutuzumab: IV infusion

BIOLOGICAL

Ublituximab

Ublituximab: IV infusion

DRUG

TGR-1202

TGR-1202: Oral daily dose

DRUG

Chlorambucil

Chlorambucil: Oral dose

Sponsors & Collaborators

  • TG Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-19
Primary Completion
2023-02-22
Completion
2023-02-22
FDA Drug
Yes

Countries

  • United States
  • Israel
  • Italy
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02612311 on ClinicalTrials.gov