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NCT04149821 · ClinicalTrials.gov registry record · Phase 2
Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04149821: Clinical Trial Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT04149821 is a Phase 2 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04149821, a Phase 2 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study evaluates the efficacy and safety of umbralisib and ublituximab (U2) as salvage therapy in patients with chronic lymphocytic leukemia (CLL) who have progressed either on a BTK inhibitor (BTKi) or BCL-2 inhibitor. The study will evaluate this combination in two parallel cohorts and subjects will be assigned based on which class of novel agent-containing regimen was used prior. Cohort A will consist of patients who progress after BTKi containing regimens and Cohort B will consist of patients who progress after a BCL-2 containing regimen. Subjects who progress on a regimen containing both a BTKi and a BCL-2 inhibitor, will be enrolled in cohort B. Each cohort will be evaluated independently of each other.
Primary Outcome
Number of subjects who achieve a partial or complete response
Interventions
- DRUG Ublituximab
- DRUG Umbralisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-02-10 |
| Est. Completion | 2022-06-09 |
| Phase | Phase 2 |
Why NCT04149821 stopped before completion
NCT04149821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Ublituximab is the first listed.
NCT04149821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04149821 about?
NCT04149821 is a clinical study titled "Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy". This study evaluates the efficacy and safety of umbralisib and ublituximab (U2) as salvage therapy in patients with chronic lymphocytic leukemia (CLL) who have progressed either on a BTK inhibitor (BTKi) or BCL-2 inhibitor. The study will evaluate this combination in two parallel cohorts and subject...
What is the current status of trial NCT04149821?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2021-02-10. Estimated completion is 2022-06-09.
What interventions are being tested in trial NCT04149821?
The interventions under investigation include: Ublituximab (DRUG), Umbralisib (DRUG).
Who is sponsoring clinical trial NCT04149821?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04149821's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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