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NCT03801525 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)
A Phase 2 study, sponsored by TG Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 277
- Enrollment target
NCT03801525: Clinical Trial Phase 2 study, sponsored by TG Therapeutics.
NCT03801525 is a Phase 2 study that was terminated before completion, run by TG Therapeutics. The registered enrollment target is 277 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (108% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03801525, a Phase 2 study, was terminated before completion, sponsored by TG Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 277 participants
- Enrollment target
Study Summary
ULTRA-V: Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL)
Primary Outcome
CR rate=percent of participants who achieved CR or complete response with incomplete marrow recovery(CRi).CR=no evidence of new disease,absolute lymphocyte count(ALC) in peripheral blood\<4x10\^9 per liter(/L),regression of nodal masses to normal size \<1.5 centimeters(cm) in longest diameter(LD),normal spleen and liver size,no constitutional symptoms,cytological/pathological evaluation of bone marrow(BM) smear/biopsy must be at least normocellular for age without evidence for typical chronic ly
Interventions
- DRUG Venetoclax
- DRUG Ublituximab
- DRUG Umbralisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2019-05-16 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 2 |
Why NCT03801525 stopped before completion
NCT03801525 is an interventional study that assigns participants to a tested intervention. The registered 277 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (108% higher).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT03801525 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03801525 about?
NCT03801525 is a clinical study titled "Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)". ULTRA-V: Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL)
What is the current status of trial NCT03801525?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 277 participants. The study started on 2019-05-16. Estimated completion is 2022-12-20.
What interventions are being tested in trial NCT03801525?
The interventions under investigation include: Venetoclax (DRUG), Ublituximab (DRUG), Umbralisib (DRUG).
Who is sponsoring clinical trial NCT03801525?
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 NCT03801525's enrollment target sits among peer trials
277 202nd of 2000 higher than 1,799 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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