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NCT04016805 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
A Phase 2 study, sponsored by TG Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT04016805: Clinical Trial Phase 2 study, sponsored by TG Therapeutics.
NCT04016805 is a Phase 2 study that was terminated before completion, run by TG Therapeutics. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04016805, a Phase 2 study, was terminated before completion, sponsored by TG Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.
Primary Outcome
U-MRD rate was defined as the proportion of participants who have undetectable MRD in the peripheral blood as confirmed by central lab.
Interventions
- DRUG Venetoclax
- DRUG Ublituximab
- DRUG Ibrutinib
- DRUG Umbralisib
- DRUG Acalabrutinib Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-08-05 |
| Est. Completion | 2022-05-22 |
| Phase | Phase 2 |
Why NCT04016805 stopped before completion
NCT04016805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 5 interventions - of which Venetoclax is the first listed.
NCT04016805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04016805 about?
NCT04016805 is a clinical study titled "Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax". Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.
What is the current status of trial NCT04016805?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2019-08-05. Estimated completion is 2022-05-22.
What interventions are being tested in trial NCT04016805?
The interventions under investigation include: Venetoclax (DRUG), Ublituximab (DRUG), Ibrutinib (DRUG), Umbralisib (DRUG), Acalabrutinib Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT04016805?
This trial is sponsored by TG Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04016805's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 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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