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NCT02656303 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304
A Phase 2 study, sponsored by TG Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT02656303: Clinical Trial Phase 2 study, sponsored by TG Therapeutics.
NCT02656303 is a Phase 2 study that was terminated before completion, run by TG Therapeutics. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02656303, a Phase 2 study, was terminated before completion, sponsored by TG Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study Summary
The purpose of this study was to provide the opportunity to the participants who progressed on treatment arm previously in the study UTX-TGR-304 (NCT02612311) to receive ublituximab (TG-1101) treatment in combination with umbralisib (TGR-1202).
Primary Outcome
ORR was defined as sum of participants with partial responses (PR) and complete responses (CR). CR: No evidence of new disease; Absolute lymphocyte count(ALC)\<4x10\^9/liter(L); Regression of all target nodal masses to ≤1.5 centimeters (cm) in longest diameter(LD); Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; Absolute neutrophil count(AN
Interventions
- BIOLOGICAL Ublituximab
- DRUG Umbralisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2016-01-07 |
| Est. Completion | 2022-07-11 |
| Phase | Phase 2 |
Why NCT02656303 stopped before completion
NCT02656303 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Ublituximab is the first listed.
NCT02656303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02656303 about?
NCT02656303 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304". The purpose of this study was to provide the opportunity to the participants who progressed on treatment arm previously in the study UTX-TGR-304 (NCT02612311) to receive ublituximab (TG-1101) treatment in combination with umbralisib (TGR-1202).
What is the current status of trial NCT02656303?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2016-01-07. Estimated completion is 2022-07-11.
What interventions are being tested in trial NCT02656303?
The interventions under investigation include: Ublituximab (BIOLOGICAL), Umbralisib (DRUG).
Who is sponsoring clinical trial NCT02656303?
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 NCT02656303's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 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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