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NCT03828448 · ClinicalTrials.gov registry record · Phase 2

Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma

A Phase 2 study, sponsored by TG Therapeutics.

Terminated
Registry status
Phase 2
Development phase
34
Enrollment target

NCT03828448: Clinical Trial Phase 2 study, sponsored by TG Therapeutics.

NCT03828448 is a Phase 2 study that was terminated before completion, run by TG Therapeutics. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03828448, a Phase 2 study, was terminated before completion, sponsored by TG Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study Summary

This is a phase 2, open label study to assess umbralisib in combination with ublituximab in participants with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).

Primary Outcome

ORR was defined as sum of participants with partial responses (PR) and complete responses (CR). CR was defined as complete disappearance of all evidence of disease and disease-related symptoms. PR was defined as regression of measurable disease and no new sites of disease. Regression= ≥ 50% decrease in sum of the products of diameters (SPD) of index lesions, with no unequivocal increase in size of other lymph nodes, liver, or spleen.

Interventions

  • DRUG Ublituximab
  • DRUG Umbralisib

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2019-07-10
Est. Completion 2022-05-31
Phase Phase 2
TG Therapeutics

33 total trials

Why NCT03828448 stopped before completion

NCT03828448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

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

NCT03828448 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03828448 about?

NCT03828448 is a clinical study titled "Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma". This is a phase 2, open label study to assess umbralisib in combination with ublituximab in participants with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).

What is the current status of trial NCT03828448?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2019-07-10. Estimated completion is 2022-05-31.

What interventions are being tested in trial NCT03828448?

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

Who is sponsoring clinical trial NCT03828448?

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

How this trial's enrollment target compares

Where NCT03828448's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03828448, the US trial registry maintained by the National Library of Medicine. NCT03828448 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.