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NCT02301156 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by TG Therapeutics.

Completed
Registry status
Phase 3
Development phase
126
Enrollment target

NCT02301156 is a Phase 3 study that has completed, run by TG Therapeutics. The registered enrollment target is 126 participants.

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The verdict

NCT02301156, a Phase 3 study, has completed, sponsored by TG Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
126 participants
Enrollment target

Study 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.

Interventions

  • DRUG Ublituximab
  • DRUG Ibrutinib

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 2015-01-27
Est. Completion 2020-04-01
Phase Phase 3

Sponsor

TG Therapeutics

33 total trials

What the Registry Record Tells You About NCT02301156

The ClinicalTrials.gov registry entry for NCT02301156 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TG Therapeutics, which has 33 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ublituximab is the first listed.

NCT02301156 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02301156 about?

NCT02301156 is a clinical study titled "Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)". 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 L...

What is the current status of trial NCT02301156?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2015-01-27. Estimated completion is 2020-04-01.

What interventions are being tested in trial NCT02301156?

The interventions under investigation include: Ublituximab (DRUG), Ibrutinib (DRUG).

Who is sponsoring clinical trial NCT02301156?

This trial is sponsored by TG Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.